Soft tissue coring biopsy devices and methods

ABSTRACT

An excisional device for either handheld or stereotactic table/MRI use may comprise a work element configured to rotate at a first rotation rate and comprising at least one articulable beak configured to cut tissue in a longitudinal direction. Helical elements or equivalent assemblies may be configured to transport tissue cut by a work element and may be co-axially disposed relative to the work element and may be operative to rotate at rotation rates that may be different from the work element rotation rate. Flush and vacuum tissue transport mechanisms may be incorporated in replacement of or in conjunction with helical elements. A proximal sheath and a distal sheath may be co-axially disposed relative to a work element and may be configured to rotate a work element and to actuate a beak or beaks. A simplified embodiment of this device may be applicable to field use where power sources for actuation may be limited.

BACKGROUND

Embodiments relate to medical devices and methods. More particularly,embodiments relate to hand held or mounted single insertion, multiplesample tissue biopsy and coring devices and corresponding methods forretrieving multiple pieces of tissue using a single insertion.

SUMMARY

Embodiments are drawn to various medical devices and methods that areused for core biopsy procedures. According to one embodiment, a biopsycoring/delivery device, also referred to herein as an excisional device,may be configured to retrieve multiple samples of normal and/or abnormalappearing biological tissues or other materials during a singleinsertion through the skin (percutaneous procedure) into the, forexample, soft or hard tissue area of the body from which the biopsy istaken. Embodiments may comprise structures and functionality fordifferent phases of a multi-phase biopsy procedure, which may beperformed by hand or by attachment to a stereotactic table stage orMagnetic Resonance Imaging (MRI) stage. For example, embodiments maycomprise a pre-treatment of the area and/or of the abnormal tissue, orthe delivery of tracer materials for tracking the potential spread orflow patterns whereby the abnormal tissues (such as cancerous tissues)may metastasize. Embodiments may also comprise an intra-proceduredelivery of medications that may anesthetize tissues at the site, or thedelivery of other therapeutic agents such as pro-coagulants and others,as well as delivery of post-procedure materials such as medications,implantable materials for cosmetic purposes and other implantableelements such as marking devices for later imaging reference.Embodiments of a biopsy device, along with associated relatedsubcomponents described herein, may provide the capability to retrievesolid, contiguous and/or fragmented tissues as well as liquid andsemi-solid tissues for analysis, diagnosis and treatment. Embodimentsmay be configured to be portable, disposable or reusable and may be, forexample, electrically-, mechanically-, hydraulic-, pneumatic- and/ormanually-powered and operated.

Accordingly, one embodiment is an excisional device, may comprise ahandle portion may comprise a distal end and a proximal end; a cuttingassembly coupled to the distal end of the handle portion and may beconfigured to rotate, core and part-off pieces of tissue; a tissuestoring magazine coupled to the proximal end of the handle portion andmay be configured to receive and store the parted-off pieces of tissue;and a transport assembly disposed at least partially within the handleportion and may be configured to receive the parted-off pieces of tissueand transport them toward the tissue storing magazine. The cuttingassembly may be configured, during a single insertion thereof intotissue, to rotate, core and part-off pieces of tissue while thetransport assembly transports the parted-off pieces of tissue and whilethe tissue storing magazine receives and stores the transported piecesof tissue.

The device may be configured, in an automatic mode of operation, tocyclically core, part-off, transport and store same-length pieces oftissue. In a semi-automatic mode of operation, the device may beconfigured to core, part-off, transport and store a single piece oftissue each time an actuator on the handle portion is actuated. Thedevice may be configured, in a manual mode of operation, to core andpart-off one or more pieces of tissue of selectable length uponactuation of a manual part-off mechanism on the handle portion. Thedevice may be configured to part-off pieces of tissue at a selectablerate. The device may be configured to part-off pieces of tissue having aselectable length. The cutting assembly may comprise one or more beaksarticulable via a living hinge. The beak(s) may be configured toselectively assume an open configuration suitable for coring and aclosed configuration suitable for parting-off tissue, tissue penetrationand/or for tissue dissection. The cutting assembly may be configured tomove, while coring, in a distal direction over a selectable excursiondistance. The cutting assembly comprises one or more hypo tubes in whichcuts are selectively made to form at least one (i.e., one or more)articulable cutting elements. The articulable cutting element(s) may beelectively actuable to assume an open configuration and a closedconfiguration.

Another embodiment is a method of excising tissue, comprising providingan excisional device that may comprise a handle portion, a cuttingassembly coupled to one end of the handle portion and may be configuredto rotate, penetrate, core and part-off tissue; a tissue storingmagazine coupled to another end of the handle portion and may beconfigured to receive and store the parted-off tissue, and a transportassembly disposed at least partially within the handle portion and maybe configured to receive the parted-off tissue and transport them towardthe tissue storing magazine; and carrying out a single insertion of atleast the cutting assembly into tissue and, during the single insertion,rotating the cutting assembly, penetrating the tissue, coring throughthe tissue and parting-off at least one piece of tissue using therotating cutting assembly, while the transport assembly transportsparted-off tissue toward the tissue storing magazine and while thetissue storing magazine receives and stores the transported tissue. Themethod may further comprise operating the excisional device in anautomatic mode of operation, to repeatedly core, part-off, transport andstore same-length pieces of tissue. The method may also compriseoperating the excisional device in a semi-automatic mode of operation,to core, part-off, transport and store a single piece of tissue eachtime an actuator on the handle portion is actuated. The method may alsocomprise operating the excisional device in a manual mode of operation,to penetrate, core and part-off one or more pieces of tissue ofselectable length upon actuation of a manual part-off mechanism on thehandle portion. The method may also comprise parting-off tissue at aselectable rate. The method may also comprise parting-off pieces oftissue having an operator-selectable length. The cutting assembly maycomprise at least one articulable beak configured to selectively assumean open configuration suitable for coring and a closed configurationsuitable for parting-off tissue, tissue penetration and/or for tissuedissection. The method may also comprise moving the cutting assemblyover a selectable excursion distance during the single insertion. Thecutting assembly may comprise a single hypo tube in which cuts areselectively made to form the articulable cutting element(s). The cuttingassembly may be selectively actuable to assume an open configuration anda closed configuration.

Another embodiment is an excisional device, which may comprise a handleportion may comprise a distal end and a proximal end; a cutting assemblycoupled to the distal end of the handle portion and may be configured torotate, penetrate, core, part-off and transporting and/or containingparted-off tissue; and a tissue storing magazine coupled to the proximalend of the handle portion and configured to receive and store theparted-off tissue. The cutting assembly may be configured to rotate,core and part-off pieces of tissue of a length determined by an amountof forward excursion of the cutting assembly within tissue before thecutting assembly parts-off the tissue sample.

The parted-off tissue contained in the cutting assembly may beconfigured to be pushed into the tissue storing magazine by a push rodinserted axially within the cutting assembly. The device may furthercomprise manual part-off actuator, configured to cause the cuttingassembly to part-off cored tissue from surrounding tissue. The cuttingassembly may be configured to rotate under power from a mechanicalwind-up motor within the handle portion. Alternatively or in addition,the cutting assembly may be configured to rotate under power from anelectrical motor within the handle portion. The cutting assembly maycomprise at least one (i.e., one or more) articulable beaks configuredto selectively assume an open configuration suitable for coring and aclosed configuration suitable for parting-off pieces of tissue,penetrating tissue and/or for tissue dissection. The cutting assemblymay comprise a single hypo tube in which cuts are selectively made toform at least one articulable cutting element. The articulable cuttingelement(s) may be electively actuable to assume an open configurationand a closed configuration. The handle portion may comprise a lowerportion and a detachable upper portion. The detachable upper portion maybe pivotably coupled to the lower portion. The cutting assembly may bedetachable from the handle portion. The tissue storing magazine may bedetachable from the handle portion. The device may further comprise aflush port through which liquids (for example) may be delivered andevacuated.

A further embodiment is a method of excising tissue, which may compriseproviding an excisional device may comprise a handle portion; a cuttingassembly coupled to one end of the handle portion and may be configuredto rotate, penetrate, core, part-off and transport or contain parted-offtissue and a tissue storing magazine coupled to another end of thehandle portion and configured to receive and store the parted-offtissue. At least the cutting assembly of the provided excisional devicemay then be inserted into tissue. The method may also comprise rotatingthe cutting assembly; advancing the cutting assembly within the tissuewhile coring, and creating pieces of tissue of a length determined by adistance the cutting assembly advanced within the tissue before beingparted-off by the cutting assembly.

The method may further comprise axially inserting and pushing a push rodwithin the cutting assembly to push the parted-off pieces of tissuecontained in the cutting assembly into the tissue storing magazine. Themethod may further comprise actuating a manual part-off actuatorconfigured to cause the cutting assembly to part-off cored tissue fromsurrounding tissue. The method may further comprise winding up amechanical wind-up motor within the handle portion to power the cuttingassembly. The method may further comprise applying electrical energy toan electrical motor within the handle portion to power at least thecutting assembly. The providing step may be carried out with the cuttingassembly comprising one or more articulable beaks configured toselectively assume an open configuration suitable for coring and aclosed configuration suitable for parting-off tissue and/or penetratingtissue. The providing step may be carried out with the cutting assemblycomprising single hypo tube in which cuts are selectively made to formone or more articulable cutting elements. The providing step may becarried out with the articulable cutting element(s) being selectivelyactuable to assume an open configuration and a closed configuration.

The providing step may be carried out with the handle portion comprisinga lower portion and a detachable upper portion. The providing step maybe carried out with the detachable upper portion being pivotably coupledto the lower portion. The method may further comprise detaching thecutting assembly from the handle portion after the pieces of tissue arecreated. The method may further comprise detaching the tissue storingmagazine, with the tissue stored therein, from the handle portion. Themethod may further comprise delivering or evacuating a liquid through aflush port provided in the handle portion.

A still further embodiment is an excisional device, comprising a handleportion may comprise a distal end and a proximal end; an articulablebeak assembly that may be configured to rotate, core through tissue andpart-off pieces of tissue from surrounding tissue; a proximal sheath,coupled to the articulable beak assembly, which may be configured toboth rotate and move in axial proximal and distal directions; a distalsheath fitted at least partially over the proximal sheath that may beconfigured to both rotate and move in the axial proximal and distaldirections independently of the proximal sheath. According to oneembodiment, differential axial movement of the proximal sheath relativeto the distal sheath opens and closes the beak assembly.

The device may further comprise a twin gear cam and cam elements withinthe handle portion, which collectively may be configured todifferentially drive respective movements of the proximal sheath and ofthe distal sheath. The device may further comprise a first carriercoupled to the distal sheath and a second carrier coupled to theproximal sheath. The distal and proximal sheaths may be configured toslide in the axial proximal direction and in the axial distal directionin response to respective axial movement of the first and secondcarriers. Each of the first and second carriers may be resilientlybiased toward the proximal end of the handle portion. An axial distanceover which the proximal carrier slides may be related to a length of thepieces of tissue parted-off by the beak assembly. The beak assembly, theproximal sheath and the distal sheath may be configured and/or operatedto penetrate tissue with the beak assembly in an open or closedconfiguration while rotating or not rotating; carry out semi-automatictissue parting-off or fully automatic tissue parting-off; and/ormanually part-off pieces of tissue of manually selectable lengths. Thedevice may further comprise a transport assembly disposed at leastpartially within the handle portion and may be configured to receive theparted-off pieces of tissue and transport them in a proximal direction.The device may further comprise a tissue storing magazine coupled to theproximal end of the handle portion, which may be configured to receiveand store the parted-off pieces of tissue transported by the transportassembly. The cutting assembly may be configured, during a singleinsertion thereof into tissue, to rotate, core and part-off tissue whilethe transport assembly transports the parted-off tissue and while thetissue storing magazine receives and stores the transported tissue. Thedevice may be configured, in an automatic mode of operation, torepeatedly part-off transport and store same-length pieces of tissue.Alternatively, the device may be configured, in a semi-automatic mode ofoperation, to part-off, transport and store a single piece of tissueeach time an actuator on the handle portion is actuated. The device maybe configured, in a manual mode of operation, to part-off one or morepieces of tissue of selectable length upon actuation of a manualpart-off mechanism on the handle portion. The device may be configuredto part-off tissue at a selectable rate. The device may be configured topart-off pieces of tissue having a selectable length. The articulablebeak assembly may be configured to selectively assume an openconfiguration suitable for coring and a closed configuration suitablefor parting-off tissue, tissue penetration and/or for tissue dissection.The articulable beak assembly may be configured to move, while coring,in a distal direction by a selectable excursion distance. Thearticulable beak may comprise single hypo tube in which cuts areselectively made to form at least one articulable cutting elements.

The device may further comprise a gear cam driven in rotation with thehandle portion; a first pin disposed against the rotating gear cam gearand may be configured to act upon the proximal sheath, and a second pinconfigured disposed away from the first pin against the rotating camgear and may be configured to act upon both the proximal sheath and thedistal sheath to drive the distal and proximal movement of the proximalsheath and of the distal sheath.

The first and second pins may be configured to be driven against therotating gear cam together or in a lead/lag relationship. The timebetween successive pieces of tissue parted-off from surrounding tissuemay be related to the speed of rotation of the gear cam. The axialdistance between the first and second pins may be related to the lengthof pieces of tissue parted-off by the articulable beak assembly.

Yet another embodiment is a method of excising tissue, comprisingproviding an excisional device comprising a handle portion, anarticulable beak assembly, a proximal sheath coupled to the beakassembly and a distal sheath fitted at least partially over the proximalsheath; inserting at least the articulable beak assembly into tissue;rotating the articulable beak assembly; and differentially moving theproximal sheath relative to the distal sheath to selectively open thearticulable beak assembly to core through tissue and to close thearticulable beak assembly to part-off cored tissue from surroundingtissue.

The providing step may be carried out with the proximal sheath beingconfigured to both rotate and move axially in proximal and distaldirections. The providing step may be carried out with the distal sheathbeing configured to both rotate and move axially in the axial proximaland distal directions independently of the proximal sheath. Theproviding step may be carried out with the excisional device furthercomprising a twin gear cam and cam elements within the handle portion,which may be configured to differentially drive respective movements ofthe proximal sheath and of the distal sheath. The providing step may becarried out with the excisional device further comprising a firstcarrier coupled to the distal sheath and a second carrier coupled to theproximal sheath. The distal and proximal sheaths may be configured toslide in the axial proximal direction and in the axial distal directionin response to respective axial movement of the first and secondcarriers. Each of the first and second carriers may be being resilientlybiased toward the proximal end of the handle portion. An axial distanceover which the proximal carrier slides may be related to the length ofthe pieces of tissue parted-off by the articulable beak assembly. Themethod may further comprise operating the articulable beak assembly, theproximal sheath and the distal sheath to penetrate tissue with thearticulable beak assembly in an open or closed configuration whilerotating or not rotating; carry out semi-automatic tissue parting-off orfully automatic tissue parting-off; and/or manually part-off pieces oftissue of manually selectable lengths. The method may further compriseproviding a transport assembly at least partially within the handleportion. The transport assembly may be configured to receive theparted-off pieces of tissue and transport them in a proximal direction.The method may further comprise providing a tissue storing magazinecoupled to the proximal end of the handle portion, which may beconfigured to receive and store the parted-off pieces of tissuetransported by the transport assembly. The method may comprise, during asingle insertion of the articulable cutting assembly into the tissue,rotating the articulable cutting assembly, coring tissue and parting-offpieces of tissue from the cored tissue, transporting the parted-offpieces of tissue in the transport assembly, and/or receiving and storingthe transported pieces of tissue in the tissue storing magazine.Rotating, coring, transporting and/or receiving and storing are carriedout simultaneously. The method may comprise operating the excisionaldevice in an automatic mode of operation in which same-length pieces oftissue are cyclically parted-off, transported and stored. The method maycomprise operating the excisional device a semi-automatic mode ofoperation in which a single piece of tissue is parted-off, transportedand stored each time an actuator on the handle portion is actuated. Themethod may comprise operating the excisional device in a manual mode ofoperation in which one or more pieces of tissue of selectable length areparted-off upon actuation of a manual part-off mechanism on the handleportion. The method may further comprise parting-off pieces of tissue ata selectable rate. The method may further comprise selecting the lengthof parted-off pieces of tissue. The excisional device may be providedwith the articulable beak assembly configured to selectively assume anopen configuration suitable for coring and a closed configurationsuitable for at least one of parting-off pieces of tissue and for tissuedissection. The method may further comprise moving the articulable beakassembly, while coring, in a distal direction by a selectable excursiondistance. The excisional device may be provided with the articulablebeak may comprise single hypo tube in which cuts are selectively made toform at least one articulable cutting elements.

The excisional device may be provided with a gear cam driven in rotationwith the handle portion and a first pin disposed against the rotatinggear cam gear and configured to act upon the proximal sheath and asecond pin configured disposed away from the first pin against therotating cam gear and to act upon both the proximal sheath and thedistal sheath to drive the distal and proximal movement of the proximalsheath and of the distal sheath. The method may further comprise drivingthe first and second pins against the rotating gear cam together or in alead/lag relationship. The method may further comprise configuring thespeed of rotation of the gear cam to be related to a time betweensuccessive pieces of tissue parted-off from surrounding tissue. Themethod may further comprise configuring an axial distance between thefirst and second pins to be related to a length of pieces of tissueparted-off by the articulable beak assembly.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a core biopsy device according toembodiments;

FIGS. 2A and 2B show details of a work element and FIG. 2B additionallyshows details of an outer or distal sheath of an excisional deviceaccording to one embodiment;

FIGS. 3A and 3B show an excisional device, according to one embodiment,with the non- or differentially-rotating outer or distal sheath removed;

FIG. 4 shows a proximal sheath comprising a plurality of elongated slotsdisposed in a spiral pattern around a longitudinal axis, according toone embodiment;

FIG. 5 shows details of a proximal sheath, beak actuation elements andinner helical element, according to embodiments;

FIG. 6 shows a non- or differentially-rotating outer or distal sheath,according to embodiments;

FIG. 7 is a view of a twin beak work assembly with an outer or distalsheath removed, according to embodiments;

FIG. 8 is a view of a twin beak work assembly with an outer or distalsheath and proximal sheath removed, according to embodiments;

FIG. 9A shows a monolithic beak assembly of an excisional deviceaccording to one embodiment.

FIG. 9B shows a detail of a proximal end of a monolithic beak assemblyof an excisional device according to one embodiment.

FIG. 10 shows the distal end of a proximal sheath of an excisionaldevice according to one embodiment.

FIG. 11 shows an assembly comprising a monolithic beak assembly and aproximal sheath of an excisional device according to one embodiment.

FIG. 12 shows the distal end of a distal sheath of an excisional device,according to one embodiment.

FIG. 13 shows an assembly comprising a monolithic beak assembly, aproximal sheath and a distal sheath, according to one embodiment.

FIG. 14 shows the distal portion of an excisional device according toone embodiment.

FIG. 15 shows the distal portion of an excisional device according toone embodiment.

FIG. 16 shows a top view of a mechanical arrangement for cutting elementrotation and actuation, according to embodiments;

FIG. 17 is an illustration of a cam and cam follower arrangement,according to embodiments;

FIG. 18 is a side view of a cutting element actuation mechanism,according to embodiments;

FIG. 19 is a side view of internal and external features of a biopsydevice; and

FIG. 20 is a side view of internal and external features of a simplifiedembodiment of a biopsy device.

DETAILED DESCRIPTION

Reference will now be made in detail to the construction and operationof implementations of the embodiments illustrated in the accompanyingdrawings. The following description is only exemplary of the embodimentsdescribed and shown herein. The embodiments, therefore, are not limitedto these implementations, but may be realized by other implementations.

Core biopsy procedures have evolved from simple core needle biopsiescomprising aspiration of fluids using a simple syringe and needle todevices having the capability to extract solid tissues forhistopathological analysis. This more recent capability has proved to bea far more powerful way to diagnose diseases and abnormal tissueentities, some of which are extremely life threatening, and others whichmay be more benign but nevertheless must be definitively distinguishedfrom the more dangerous types of abnormalities, including cancerous andpre-cancerous lesions, in-situ cancers, invasive cancers, benign spaceoccupying lesions, cystic lesions and others. As core biopsy procedureshave evolved into far more diagnostically powerful tools, they havedisplaced many of the more invasive open surgical procedures, which hadbeen and continue to be performed for diagnostic purposes. One of themost critical needs during a biopsy procedure is to accurately correlatetissue diagnosis with imaging diagnosis. In order to successfullyaccomplish this, it is essential to know that the retrieved tissueactually and accurately represents the imaged abnormality. This is anaspect where many conventional coring devices fall short, and for thisreason, open surgical diagnostic procedures and other invasiveprocedures continue to be performed. Other clinically significantlimitations of conventional coring devices include the manner in whichthe abnormal tissue is separated from the host organ, the manner inwhich the tissue is retrieved and handled during the process by thecoring biopsy device, and the amount of biopsy artifact/damage impartedto the tissue specimens by the coring procedure and device. It is wellknown that the larger the caliber of the retrieved tissue samples, thebetter the correlation with the imaging abnormality, and thus theeasier, more accurate, definitive and helpful the diagnosis. However, inorder to retrieve larger caliber specimens, most biopsy devices havelarge outer diameters, leading to increased trauma, complications, painand other adverse effects, due principally to the imprecision associatedwith such large bore devices. Additionally, moving a large bore devicethrough the tissues is much more difficult, particularly without thehelp of an active mechanism to aid in smoother and more gradualadvancement of the biopsy device. The larger the caliber of the biopsydevice, the more difficult it becomes to precisely visualize the biopsydevice in relation to the target abnormality, especially for smalllesions (on the order of about ½ cm to less than ¼ cm). Today, more than4-5 million diagnostic core biopsies are performed each year around theworld in the breast alone, with as many as 2 million diagnostic breastbiopsies being performed each year in the US. There is little doubt thatmany invasive, open surgical diagnostic biopsies should be replaced byimproved core biopsy procedures.

Reference will now be made in detail to the construction and operationof preferred implementations illustrated in the accompanying drawings.FIG. 1 shows a biopsy or, more generally, an excisional device 10according to embodiments, having a tubular coring and transport assembly11 (also called an “outer tube,” “distal sheath,” “non- ordifferentially-rotating outer sheath” or “outer sheath” herein,depending on embodiments) of appropriate dimensions to retrieve a singleor multiple core samples of tissue (not shown) that is or are sufficientto provide the desired clinical diagnostic or therapeutic result. Suchan appropriate dimension may be, for example, about 6 inches in length,in addition to a forward excursion of a tubular coring and transportassembly 11 during the coring phase. It is to be understood, however,that the foregoing dimensions and any dimensions referred to herein areexemplary in nature only and are not limiting factors. Those of skill inthis art will recognize that other dimensions and/or configurations maybe implemented, depending upon the application, and that a tubularcoring assembly and its subparts could be of any length.

One embodiment of the biopsy device 10, as shown in the figures, may beimplemented in a hand-held configuration comprising an ergonomicallycomfortable and secure handle portion 12 at its proximal end from whicha tubular coring and transport assembly 11 extends so that the biopsydevice 10 may be easily directed with one hand while the other hand isfree to hold a guiding probe such as an ultrasound transducer. However,it is to be understood that embodiments may readily be configured to fitonto any number of guiding devices such as a stereotactic imaging stageor other guidance modality such as MRI (not shown). As shown, oneembodiment of the biopsy device 10 may comprise one or more sharp,rotating cutting elements 13 (herein, alternatively and collectivelyreferred to as “work element”, “beak”, “beak assembly” or “beak element”or “beak elements”) projecting forward distally from the distal free endof the tubular coring and transport assembly 11 for the purpose offorward penetration, coring and parting off of a cored sample in asimple point and shoot procedure. A tubular coring and transportassembly 11 may comprise a plurality of components, which plurality maybe configured to transmit rotational movement to rotating ornon-rotating cutting elements 13. It is to be understood that the“tubular” description of a coring and transport assembly may be of anycross section shape and size, of any length. The components of a tubularcoring and transport assembly 11 also transfer a core sample (or pieceof tissue, the present device not being limited to biopsy applications)back proximally along the internal length of an inner lumen of a tubularcoring and transport assembly 11 to a handle portion 12 and storagecompartment or a transfer magazine 27. According to one embodimentthereof, the biopsy device 10 may comprise handle portion 12, whichhandle portion 12 may comprise and/or be coupled to mechanicalcomponents (not shown in this figure) needed to drive acoring/transport/part-off/delivery distal tubular coring and transportassembly 11. As shown, one embodiment may comprise a distally-disposedbeak 13 that may comprise one or more sharp cutting tip blades topenetrate to the target site of the intended biopsy, core the targettissue and part-off or cut off a core sample (not shown) at its base orat any desired point along the length of a core sampling. The ability ofthe present biopsy device to repeatedly core and retrieve multiplesamples (not shown) during a single insertion and then store the coredsamples in a transfer magazine 27 means that with a single penetrationthrough the skin of, for example, a human breast, the operator cansample multiple areas without causing additional trauma that would beassociated with having to remove the biopsy device 10 each time a sampleis taken, and reintroducing the biopsy device 10 back into the patientto take additional core samples. A handle portion 12 may also containand/or be coupled to (internal or external) mechanical components (notshown) for vacuum-assisted fluid evacuation as well as the delivery ofmaterials such as, for example, a variety of flushes, medications,tracer materials and/or implantable marker elements (not shown). Adistal tubular coring and transport assembly 11, according to oneembodiment, may be configured such as to create the smallest possiblecaliber (e.g., diameter) of coring tube (tubular coring and transportassembly 11) with a range of (for example) about 16 gauge or 0.065inches in diameter to about 1 inch or more diameter, while providing asufficiently large diameter of core sample to be clinically useful. Atubular coring and transport assembly 11 may also be constructed offlexible materials and/or of a sufficient length to reach distant targetsites from the skin surface without the need for a surgical procedure toenable the distal end (that end thereof that is furthest from a handleportion 12) of the biopsy device 10 to reach the targeted site. In theembodiment of FIG. 1, a distal tubular coring and transport assembly 11of the biopsy device 10 may extend distally from a handle portion 12 toa distance sufficient to create a tissue core (not shown) for diagnosisand/or treatment purposes. As is described below, this distance offorward or distal projection can be selectively changed at will, thanksto structure configured for that purpose, which may be built into orotherwise coupled to the present biopsy device 10. Embodiments of thepresent biopsy device 10 may be used by right and/or left handed personsand in multiple positions and orientations so that in areas of limitedaccess the present biopsy device may still be easily positioned forideal orientation to perform a biopsy procedure under real time or otherimage guidance (not shown). The entire device may be configured to bedisposable or may be configured to be reusable in whole or in part.Embodiments of the present biopsy device 10 may be electrically poweredby one or more batteries (not shown in this figure) and/or externalpower sources (not shown in this figure) through a simple electricalcoupling to connect to an external power supply conveniently placed, forexample, in a handle portion or proximal end of the present biopsydevice. The entire device may also be internally or externally manuallypowered, mechanically powered or be powered by means such as compressedair, gas or pressurized fluid. Powering the biopsy device entirelymechanically may be advantageous in areas in which the electric grid isabsent, unavailable, or unreliable. In FIG. 1, the biopsy device 10 isshown in a pre-coring configuration with the distal end thereof closedand in a configuration in which it may be partially projecting forwardfrom its resting position from a proximal handle portion 12. FIG. 1 alsoshows illustrative placement of various external controls such as manualpart off lever 633, and cam clutch button 634, as well as other featuressuch as power switch/led indicator 635, motor 636 and DC power plug 637.The placement of these features is illustrative in nature andembodiments may contain some or all of these features in variouslocations.

According to one embodiment, a method of carrying out a biopsy proceduremay comprise the following example, based on breast biopsy procedureswhich ordinarily begin with imaging the tissue of the organ (such as thebreast) of interest and identifying the target lesion(s) or tissue to beremoved. The skin may then be cleansed using sterile techniques, and thepatient may be draped and anesthetics may be delivered. The distal tipof the present biopsy device may then be introduced through a skin nickincision. Further still, a guiding element could be coaxial with, intandem with or adjacent to the long axis of elements of the biopsydevice. A guiding element could additionally be a completely separableentity, such as a removable outer sheath that may function as a locatingtube, which may be pre-placed by an operator skilled in imaging andtargeting and fixed in place near or within the target tissue. Afterplacement and fixation an operator may then proceed by advancing thebiopsy instrument over a previously precisely placed and anchoredguiding element.

The biopsy device may be advanced percutaneously to the target tissuesite and fluids or anesthetics may be delivered during that process. Anoptional delivery stage may also be initiated, to deliver, for example,the contents of a preloaded cartridge such as tracer elements likevisible dyes, echo-enhancing materials and/or radioactive tracerelements, or others, for example, medications such as epinephrine oranesthetics which may be delivered at any stage of the biopsy procedureeither directly through open beaks, through living hinges of closedbeaks or via a reverse flow from a flush system built into the device.Tissue samples may then be taken in manual, automatic or semi-automaticmodes. If short samples or very long samples are desired, the operatormay manually part off the sample to be taken at any length of theforward movement of cutting elements and/or the device itself. Fluidflushes containing material from the tissue site may be collected byaspiration for later cytological analysis. During one or more of thecorings, a record stage may be activated to halt a coring stage justafter the specimen has been parted-off in order to enable thepractitioner to record image(s) of the shaft of the biopsy device inplace in the lesion, and to document that core samples (particularlythose of different chosen lengths obtained serially during theprocedure) were acquired precisely from imaged lesions or in preciselocations within imaged lesions. A removable magazine 27 may be placedinto a receptacle that may be preloaded with fluid such as, for example,sterile saline or preservative, and then such receptacle may be sealed.A specimen ultrasound or a radiograph may be carried out upon thespecimens collected within a transfer magazine 27, which may beespecially configured for echo and radio-lucency as well ascompatibility with MRI and other imaging technologies. If desired, areplacement magazine 27 may be loaded into the device to continue thebiopsy. An adapter for delivery of aforementioned materials to thebiopsy site may be substituted for a magazine 27 at any time. Followingthe acquisition of a sufficient number of core samples and following thedocumentation stage, the core sample acquisition site may be firmlycorrelated with the image abnormality location. With the biopsy device10 still in place, a tissue transfer magazine 27 may be replaced with aninjection cartridge (not shown) that may be pre-loaded withintra-procedure and/or post-procedure elements, for example,medications, cosmetic implants, brachytherapy elements such as aradio-active seed, or a porous element loaded with a biologically activesubstance and other materials. A replacement transfer magazine 27 may beremoved at the end of the procedure. A removable transfer magazine 27may then be placed into a receptacle that may be preloaded with fluidsuch as, for example, sterile saline or preservative, and suchreceptacle may be sealed. The present biopsy device may then be removedfrom the site and the wound may be dressed, with the usual standard ofcare procedures. Alternatively, the biopsy device 10 may be withdrawnfrom a removable outer sheath, present according to embodiments, whichouter sheath may then be used for delivery of post-procedure materialsto the target site while other components of the biopsy device may bepackaged appropriately and delivered to an appropriate laboratory forpathology/cytology analysis. An outer sheath of the biopsy device maythen be completely removed from the site and the wound dressed using thecustomary standard of care procedures. If so attached to biopsy device10 via an aspiration/material delivery port 639, a liquid aspiratecollection vessel may be removed from biopsy device 10 at any time andcapped securely for transport to an appropriate laboratory for cellularand subcellular analysis.

It is to be understood that the above description is but one exemplarymethodology and that one or more of the steps described above may beomitted, while other steps may be added thereto, depending on the targetsite within the body, which is not limited to the breast, or otheroperator methodologies. The order of some of the steps may be changed,according to the procedure.

Turning now to further embodiments and in more detail, the discussionthat follows will focus on general features of a whole device 10, whichmay comprise a distal end consisting of an outer sheath, a distalsheath, a proximal sheath, work element or elements and may alsocomprise first, second and third helical elements, in any combination orcombinations of the above according to embodiments, as well as otherelements such as suggested by FIG. 1 and as detailed further below,starting from the distal end and continuing to the proximal end of adevice 10.

FIG. 2A shows that a first, or according to embodiments, first andsecond or more articulable beaks (one of which may be fixed or rigid ornon-articulable, according to embodiments) may comprise one or moreslots 462 therein to form a living hinge 458. Additionally, wedge-shaped(for example) cutouts 466, which may be left joined at the base of awedge adjacent to slots 462, may be provided to define an articulablebeak(s) of a work element 13, improve the articulation thereof andprovide for a greater range of motion. These living hinges may alsoserve as conduits for medications (anesthetics and epinephrine, forexample) and other liquids, for example, saline flushes, to flow througha central lumen of the device for delivery to the distal end of thedevice 10, even if such beak(s) may be closed during such anintra-operative procedure. According to embodiments, each of a first andsecond articulable beak tips 452, 454 may define a first tendon 468coupled to one side of a first articulable beak and a second tendon 470coupled to the other side of a first articulable beak. Alternatively, asingle tendon may be defined or multiple tendons may be defined.Additionally, these tendons may be defined at different relative anglesto each other to impose an unequal or asymmetrical force to the sides ofthe distal end of one or more of the articulable beak tips, according toembodiments. As shown, these first and second tendons 468, 470 may beconfigured to selectively apply a proximally-directed force and adistally-directed force to the distal portion to cause a first andsecond articulable beak tips 452, 454 to assume their closed and openconfigurations, respectively, or in the case of a single beakconfiguration, to open or close against a fixed or non-articulable beak(not shown in this view). Indeed, pulling on the first and secondtendons 468, 470 by a proximal force acting on actuating element 469tends to close the first and second articulable beak tips 452, 454(i.e., draw the respective distal tips closer to the longitudinal axisand closer to one another). Pushing on the first and second tendons 468,470 tends to open the first and second articulable beak tips 452, 454(i.e., draw the respective distal tips away from the longitudinal axisand away from one another).

FIG. 2B shows a work element (shown as cutting elements 13 in FIG. 1 forclarity) consisting in one embodiment of twin articulable beaks 516 and518 (numbered differently in this illustration to indicate that anentire beak or beaks may be comprised of many features already outlinedin FIG. 2A) and outer or distal sheath (an outer sheath and a distalsheath may both be present in embodiments) of an excisional deviceaccording to embodiments. As shown, an excisional device, according toone embodiment, may comprise an outer or distal sheath 590 defining alongitudinal axis whose distal end, as shown, may comprise a variety ofshapes, such as wavy or sinusoidal shapes or other leading edge shape,with such leading edge being sharpened around its circumference andsides as desired. A work element may be configured to at least partiallyfit within an outer or distal sheath 590 and be configured to bewithdrawn into the distal sheath 590 and extend out of its tip whilelying within its curvature. A work element, according to one embodiment,may comprise a single articulable beak with an opposing fixed beak, orof first and second (or more) articulable beaks 516 and 518 as shown inthis figure, according to various embodiments, and configured to rotatewithin an outer or distal sheath 590 about the longitudinal axisthereof, as shown at 517. As shown in this figure, first and secondarticulable beaks 516, 518 may define respective first and second curveddistal surfaces configured to cut tissue. The work element may befurther configured to be advanced distally such that at least first andsecond curved distal surfaces of a beak or first and second articulablebeaks are disposed outside of an outer or distal sheath. As particularlyshown in FIG. 6, a portion of both first and second curved surfaces of asingle beak or first and second articulable beaks 516, 518 may beconfigured to rotate outside of an outer or distal sheath 590, with theremaining portions thereof rotating within an outer or distal sheath590. Indeed, in this embodiment, a substantial portion of first andsecond articulable beaks 516, 518 may be configured to rotate within anouter or distal sheath 590. This configuration radially supports firstand second articulable beaks 516, 518, and prevents them fromover-extending or otherwise undesirably deforming when cutting throughtough tissue. According to one embodiment, a shearing or scissors actionmay be imparted, as the distal tips of first and second articulablebeaks 516, 518 rotate inside the extremity of an outer or distal sheath590 and act with their sharpened edges against the side edges of such anouter differentially- or non-rotating sheath 590. However, first andsecond articulable beaks 516, 518 may also be configured to extendfurther out of an outer or distal sheath 590, and in either a closed oropen beak configuration. A closed beak configuration wherein a workelement extends only to the distal opening of an outer or distal sheath590 may be well suited to advancing through tissue to the intendedlesion site, with closed first and second articulable beaks 516, 518blocking tissue entry into a central lumen as the tip of the deviceadvances through the tissue. Alternatively, such extension of first andsecond articulable beaks 516, 518 outside of an outer or distal sheath590 may constitute a phase of a combined rotational/closing and part-offaction following coring of the tissue accomplished with first and secondarticulable beaks 516, 518 at least partially enclosed within an outeror distal sheath 590. Finally, extension of first and second articulablebeaks 516, 518 in either the closed or open configuration may beaccomplished either by extension of a work element and/or retraction ofa distal sheath 590 in relation to cored or to-be-cored tissue, as willbe illustrated later in figures. To limit the extent of force that maybe applied to first and second tendons 468, 470 and thus on first andsecond articulable beaks 516, 518, a work element 13 may comprise travellimiter structures 467 (only one of which is visible in FIG. 2B).Indeed, as shown in FIG. 2B and according to one embodiment, the travelin the distal and proximal directions of beak actuating elements 469 maybe limited by interlocking tab and slot features of any shape that onlyallow a limited relative travel between the constituent elementsthereof. Such limited travel is sufficient, according to one embodiment,to fully open and to fully close first and second articulable beaks 516,518.

Slots, such as for fluid delivery or vacuum, may be provided within anouter or distal sheath, as shown at 520. Should a vacuum be drawn withinthe lumen of an outer sheath 590, surrounding tissue may be drawnthereto, thereby assisting in stabilizing the distal end of theexcisional device during the specimen cutting procedure. Vacuum slotsmay also serve to collect liquids and free cells from the surroundingtissue or to deliver liquids to the surrounding tissue. They may alsoserve as an opening at the distal end of the device so that as vacuum isapplied internally at the proximal end of a distal (e.g., outer, in thisillustration) sheath 590 as an aid in transporting tissue specimensproximally, a corresponding vacuum is not built up behind (distally) thetissue specimens, which may prevent them from acting as plugs in a workelement.

The shape of sharp cutting elements or beaks in assembly 13, such as theembodiment thereof shown in FIGS. 2A and 2B, for example, providessubstantial support vectors for all movements required of such cuttingblades during rotation, opening/closing and axial motions (not shown).Using the nomenclature of FIG. 1 in particular, this embodiment enablessharp cutting elements of beak assembly 13 to be made extremely thin,which fulfills a requirement that for any given outer radial dimensionof a tubular coring and transport assembly 11, including a cutting beakassembly (see also FIG. 1), the caliber of the core sample retrievedfrom the patient will be as large as possible. The shape(s) of sharpcutting elements of beak assembly 13 specified for use in coring andpart-off, according to embodiments, enable the biopsy device 10 toobtain a full diameter core sample, and in fact larger than fulldiameter due to dimensions of a coring and transport assembly 11, ofwhich slightly larger caliber (e.g., diameter) may be desirable in orderto compress, “stuff”, or pack in as much tissue sample as possible intoa tubular coring and transport assembly 11. Coring of a larger than fulldiameter tissue sample may prove advantageous from diagnostic andclinical standpoints, by providing more sample (not shown) for analysisor by removing as much of the target tissue as possible during a singleexcision.

According to one embodiment and as described herein, the work element 13of FIG. 1, including articulable beak(s) 516 and 518 of FIG. 2B, may beconfigured for rotation within an outer non- or differentially-rotatingouter or distal sheath(s), such as 590 of FIG. 2B. Moreover, articulablebeak(s), according to one embodiment, may comprise a surface havingsubstantially the same curvature as the body portion. Indeed, FIG. 15shows that the radius of curvature RC1 of the body portion of the workelement is the same as the radius of curvature RC2 of the articulablebeaks at the distal end thereof. According to one embodiment,articulable beak(s) may be generally described as being or comprisingone or more hyperbolic segments of one or more sections of a hollowcylinder, such as a hypo tube. Variations including complex curves maybe incorporated into the shape of articulable beak(s), to optimizefunction in different sections of the edges of articulable beaks.Moreover, first and second articulable beaks, according to embodiments,may have slightly different shapes from one another. The angle formed bythe distal portion of first and second articulable beaks may be, forexample, from about 5 to 50 degrees. According to one embodiment, theangle may be between about 10 and 30 degrees. According to anotherembodiment, the angle formed by the distal portion of first and secondarticulable beaks may be about 18 degrees.

Note that, according to one embodiment, an entire work element,including first, or first and second (or multiple) articulable beaks 516and 518, along with their first and second tendons, beak actuationmechanism 469, living hinges 458 (as shown in FIG. 2A) connecting firstand second articulable beaks to a body portion of a work element, travellimiter structures and, as described below, a first helical element maytogether be a single monolithic structure formed of a same material thatmay be (e.g., laser-) cut from, for example, a single solid hypo tube.That is, these structures may be formed together of a same piece ofunbroken homogeneous material.

Continuing to describe additional elements of a tubular transport andcoring mechanism 11 of FIG. 1, according to embodiments, FIGS. 3A and 3Bshow an intermediate, proximal sheath 584 of an excisional device 10,according to one embodiment, with a non- or differentially-rotatingouter or distal sheath 590 removed. According to one embodiment, aproximal sheath 584 may be configured to fit over at least a portion ofa work element (as shown later in FIG. 7) and abut collar 542, whichcollar may be nothing more than an internal shoulder within a distal (orouter) sheath 590, such as 593 in FIG. 6 below. According to oneembodiment, a proximal sheath 584 may be configured to resiliently biasa first and second articulable beaks 516 and 518, if double (ormultiple) beaks are used, in the open position. According to oneembodiment, a proximal sheath 584 may be slid over a work elementproximal portion and advanced over a work element until the distal endthereof abuts against a collar 542 (or shoulder 593 of FIG. 6).Therefore, as will be shown later in FIG. 7 and other figures,selectively acting upon (e.g., exerting a proximally-directed ordistally-directed force) a proximal sheath 584 by action on its proximalportion 548 causes a first and second articulable beaks 516, 518 to openand close, in concert with a distal sheath 590 of FIG. 6 over at least aportion of a work element. In such an embodiment, a proximal sheath 584may itself be enclosed by an outer non- or differentially-rotatingdistal sheath 590, effectively capturing the distal portion 546 of aproximal sheath against a distal sheath 590, as shown in FIGS. 6 and 7further on. According to one embodiment, a proximal sheath 584 may beeither free floating or driven in rotation. According to anotherembodiment further detailed below, a collar 542, which is primarilyshown for illustrative purposes of one embodiment, may be eliminated anda beak actuating element (469 of FIGS. 1A and 2B above) of a workelement may be directly attached to the distal end of proximal sheath584 at the distal and proximal ends of a helical portion 544 of aproximal sheath. In such an embodiment, a work element may be attachedto a proximal end of a helical element 544 to rotate a work element(including a first and second articulable beaks). In this manner, aproximal sheath 584 may be configured to entrain a work element inrotation as well as to open and close articulable beaks. In such anembodiment, an inner or first helical element, such as will be shown inFIG. 5, may be decoupled from a work element, thereby enabling suchinner or first helical element to be driven at a rotational speed thatis independent of the rotation speed of a connected proximal sheath andfirst or first and second articulable beaks 518 or 516, 518, as is shownand discussed in greater detail below. According to one embodiment, tobias a first and second articulable beaks 516, 518 in the open position(at least partially within an outer or distal sheath 590, according toone embodiment), a proximal sheath 584 may comprise a second helicalelement 544. In this manner, according to one embodiment, not only maythe present excisional device comprise first or first and second helicalelements, but such helical elements may be co-axially arranged withinthe device, one over the other. According to one embodiment, at least aportion of a second helical element may fit over a first helical elementwithin the excisional device, to effectively define a structurecomprising a coil-within-a-coil.

It is to be noted that, herein, the phrase “helical element” and theterms “helix” or “helices” are intended to encompass a broad spectrum ofstructures. Indeed, the structures shown herein are but possibleimplementations of a helical element, helix or helices. According toother embodiments, “helical element”, “helix” or “helices” andequivalent expressions may be implemented as tubes having one or moreslot-shaped openings or fenestrations along at least a portion of thelength thereof. Such fenestrations may be substantially parallel to thelongitudinal axis of a tube or may be disposed, for example, in a spiralconfiguration. The fenestrations may be continuous along at least aportion of the length of a tube or may be discontinuous, such as toresult in a plurality of such parallel or spirally wound fenestrations.The fenestrations may be very wide such that the resultant structureresembles a spring, or more narrow, such that the resulting structuremore closely resembles a tube having narrow, slot-shaped openingstherein. The continuous or discontinuous fenestrations may be caused toassume other configurations along at least a portion of the tubes inwhich they are formed. For example, the fenestrations may be caused toform a zigzag pattern such as “NNNN . . . ”, “

” or “VVVV . . . ” or a cross-shaped pattern, such as “XXXXX”.Significantly, the terms “helical element,” “helix,” or “helices” shouldbe understood to cover a spectrum of structures, from a spring-likestructure to tubes having selected slot-shaped openings.

According to one embodiment, a proximal sheath 584 may comprise a distalregion 546 comprising a second helical element 544 and a proximal region548. A region 548 may be generally co-extensive with at least a portionof a first helical element, if included in such embodiment, of a workelement and may comprise structure configured to aid in the proximaltransport of a severed tissue specimen. Indeed, after being severed fromsurrounding tissue, the cored specimen may be urged in the proximaldirection within the body portion of the work element and eventuallyengage such a rotating first helical element, if present, along with aflush conduit to aid tissue transport. A first helical element, ifpresent according to embodiments, may assist in the transport of thecored specimen to a tissue collection magazine 27 of FIG. 1 coupled tothe present excisional device 10. Surface features may be provided onthe surface of an inner lumen of a proximal sheath 584. Such features,however configured, may aid in the transport of cored specimen byproviding some measure of friction between the cored specimen and arotating first helical element, if used, to enable the cored specimen tomove in a proximal direction through the device. According to oneembodiment and as shown in FIGS. 5 and 7 further on, when a proximalsheath 584 is fitted over a work element, tissue entrained by a firsthelical element, illustrated by 582 of FIGS. 5 and 8, will also be drawnagainst an inner lumen of a proximal sheath 584. According toembodiments, a flush and a vacuum may be drawn within at least aproximal sheath 584. In this manner, cored tissue specimen(s) may bedrawn through coils of a first helical element, if present, to come intointimate contact with the (e.g., patterned or slotted) surface of aproximal sheath's inner lumen, and tissue specimen transport may beaided by flush and/or vacuum drawn within such proximal sheath's innerlumen. In other embodiments, only the flush fluid and vacuum, acting inconcert but without a first helical element, may suffice to ensuretissue specimen transport to, for example, a transfer magazine.

FIG. 4 shows a proximal sheath 584 comprising a plurality of elongatedslots disposed in a spiral pattern around a longitudinal axis, accordingto one embodiment. As shown in FIGS. 3A and 3B, and according to oneembodiment, a proximal sheath 584 may define one or more elongated slots552 therein. Such slots 552 may allow fluid communication with aninterior lumen of a proximal sheath 584. In other words, the slot orslots 552 may go all of the way through the wall thickness of a proximalsheath 584. For example, when vacuum is drawn within a central lumen ofa proximal sheath, cored tissue specimens being transported by a firstrotating helical element 582, if used, may be drawn to slots 552, andpartially invaginated therein, to provide some resistance to the coredtissue specimen, thereby preventing the specimen(s) from simply rotatingin place within a first helical element without moving. Slots 552 mayalso serve as controllable conduits for flushing liquids used to aidtransport in concert with aspiration applied from a vacuum source withinor external to the device 10. According to one embodiment, slots 552 maybe serially disposed end-to-end substantially parallel to thelongitudinal axis of a proximal sheath 584, as shown in FIG. 3A, or maybe offset relative to one another, or may be disposed in a spiralpattern (whether non-overlapping or overlapping, as shown in FIG. 4),thus effectively acting as an elongated co-axially disposed thirdhelical element of similar or different pitch than a second helicalelement, similar to that discussed under FIG. 3B above.

FIG. 5 shows details of a proximal sheath, beak actuation elements andan inner first helical element, according to embodiments. It is to benoted that the figures herein are not to scale and the relativedimensions of any constituent elements of the excisional device 10 mayvary from figure to figure. According to one embodiment, the working end(e.g., substantially all structures distal to the handle portion 12) ofthe excisional device 10 may be essentially composed or formed of two ormore separate elements that are disposed substantially concentrically orco-axially relative to one another. This results in a mechanicallyrobust working end of the excisional device that is economical tomanufacture and to assemble.

As shown in the exploded view of FIG. 5, one embodiment describes a workelement that comprises body portion 428 and tendon actuating elements469 (only one of which is shown in this view), and may be terminated byfirst and second articulable beaks (not shown in this view). A firsthelical (tissue transport) element 582 may be formed of the samematerial as a work element. According to one embodiment, a work element(i.e., body portion 428, tendon actuation element 469 and first or firstand second articulable beaks) and a first helical element may be cut orformed from a single piece of material, such as a hypo tube. Forexample, hypo tube may be suitably (e.g., laser) cut to form bodyportion 428, tendon actuation elements 469, first and second articulablebeaks and a first helical element 582. A first helical element 582 maythen be mechanically decoupled from a work element by cutting the twostructures apart. These two structures are, therefore, labeled (1 a) and(1 b) in FIG. 5, to suggest that they may have been originally formed ofa single piece of material. That a first helical element is mechanicallydecoupled from a work element enables the rotation of a first helicalelement 582 to be independent of the rotation of a work element. Forexample, a first helical element 582 may rotate at a comparativelyslower rate than the rate of rotation of a work element, as transport ofsevered tissue specimen may not require the same rate of rotation as maybe advisable for a work element. According to one embodiment, a firsthelical element 582 may rotate slower than a work element of theexcisional device.

The second of the three separate elements of the working end of theexcisional device, in this embodiment, is a proximal sheath 584, asshown at (2) in FIG. 5. A proximal sheath 584 may comprise, near itsdistal end, a second helical element 585. As shown in FIG. 5, a secondhelical element 585 may be disposed concentrically over a portion of afirst helical element 582. According to one embodiment, a proximalsheath 584 may comprise one or more proximal locations 586 and one ormore distal locations 587. Proximal and distal locations 586, 587 maydefine, for example, indentations or through holes and may indicate theposition of, for example, spot welds (or other attachment modalities)that may be configured to mechanically couple a proximal sheath 584 witha work element 1 a (or 13, as shown in previous figures) of theexcisional device. When assembled, a proximal sheath 584 may beconcentrically disposed over a first helical element 582 and advancedsuch that one or more proximal locations 586 on a proximal sheath 584are aligned with corresponding one or more proximal attachment locations588 on a work element, and such that one or more distal location orlocations 587 on a proximal sheath 584 is or are aligned withcorresponding one or more distal attachment location(s) 589 on a tendonactuating element 469. The corresponding locations 586, 588 and 587, 589may then be attached to one another. For example, one or more proximallocations 586 on a proximal sheath 584 may be spot welded tocorresponding one or more proximal attachment locations 588 on a workelement, and one or more distal locations 587 on a proximal sheath 584may be spot welded to corresponding one or more distal attachmentlocations 589 on tendon actuating elements 469.

It is to be noted that locations 586, 587, 588 and 589 shown in thefigures are illustrative and exemplary only, as there are many ways ofmechanically coupling or attaching a proximal sheath 584 to a workelement, as those of skill may recognize. According to one embodiment, aproximal sheath 584 may be attached such that movement of a secondhelical element 585 (e.g., extension and compression) correspondinglyactuates first and second articulable beaks between a first (e.g., open)configuration and a second (e.g., closed) configuration. Indeed, aproximal sheath 584 may be mechanically coupled to a work element of theexcisional device such that, for example, a proximal portion thereof(e.g. at or in the vicinity of proximal locations 586) is attached tothe body portion 428 of a work element and such that a distal portionthereof (e.g., at or in the vicinity of distal location 587) may beattached to tendon actuating elements 469. In this manner, compressionand extension of a second helical element 585 may cause a relativedisplacement of tendon actuation elements 469 and a body portion 428(i.e., one may move while the other is immobile or substantially so, orboth may move relative to one another), thereby causing the actuation offirst and second articulable beaks.

FIG. 6 shows a non- or differentially-rotating distal sheath 590, whichmay or may not, according to embodiments, extend over first or first andsecond articulable beaks. A third of three coring and transportmechanism 11 elements, according to embodiments, is a distal sheath 590which may be configured to fit over a work element as shown in FIG. 5comprising a body portion 428, a tendon actuating element 469 and atleast a portion of a first or first and second articulable beaks. Anouter or distal sheath 590 may also be configured to slide and fit overa proximal sheath 584 that is mechanically coupled to a work element,and may have slots, similar to 552 of a proximal sheath 584 of FIG. 4(which may essentially define a fourth helical element). An outer ordistal sheath 590, according to one embodiment, may comprise a distalportion 592 (shown extended to the tips of the beaks within, but whichmay be shortened all the way to just distal of shoulder 593) having afirst diameter and a proximal portion 594 having a second diameter. Asecond diameter may be larger than a first diameter. To accommodate thedifferences in diameters of first and second portions 592, 594, a distalsheath may comprise a shoulder 593 with a surface that transitionsbetween distal and proximal portions 592, 594 of differing diameters andagainst which the distal portion of a second helical element 585 of FIG.5 may act, in one embodiment.

FIG. 7 is a view of a two beak assembly with a distal sheath 590removed, according to embodiments. FIG. 7 shows components of a workelement (comprising, e.g., body portion 428, one of a tendon actuationelements 469 and first and second articulable beaks 602, 604)mechanically coupled to a proximal sheath 584. As suggested at 586, 588and at 587, 589, a proximal sheath 584 may be spot welded to a workelement in such a manner as to enable differential motion of a bodyportion 428 of a work element relative to the tendon actuating elements469 thereof when a second helical element 585 compresses and extends,which differential motion actuates (e.g., opens and closes) first andsecond articulable beaks 602, 604. Significantly, the attachment of aproximal sheath 584 to both a body portion 428 and to tendon actuatingelements 469 of a work element results in substantially equal torquebeing imposed on the constituent elements of a work element, therebymaintaining the structural integrity of a work element as it is spun upto speed (by rotating a proximal sheath 584 in this embodiment) and asfirst and second articulable beaks 602, 604 cut through variably dense,fibrous and vascularized tissues.

FIG. 8 is a view of a multiple beak 602, 604 assembly with an outer ordistal sheath and proximal sheath removed, according to embodiments.FIG. 8 shows a body portion 428, tendon actuation element 469 and firstand second articulable beaks 602, 604 of a work element 13 together witha first helical element 582. A proximal sheath 584 and a distal sheath590 are not visible in this view. As shown, a first helical element maybe co-axially disposed relative to a body portion 428 of a work elementand may be of the same or substantially the same diameter. As notedabove, the two may be formed of or cut from a single piece of materialsuch as, for example, a stainless steel hypo tube. According to anotherembodiment, a first helical member may be of a different diameter than abody portion 428. However, such an embodiment may require correspondingchanges to the diameters of a proximal sheath 584 and a proximal portion594 of a distal sheath 590 and a change to the shoulder 593, aspreviously illustrated herein. Thus far and according to the previousfigures as discussed above, embodiments of a tubular coring andtransport assembly (FIG. 1) of the device may comprise first (transportor inner helix), second (beak actuation helix of the proximal sheath)third (proximal sheath slots) and even fourth (distal sheath slots)helices co-axially disposed to each other. Embodiments discussed inlater figures will show other configurations wherein there may be lessthan three co-axially disposed helical elements in device 10.

FIGS. 9A and 9B show another embodiment of a work element, according toone embodiment. Attention is drawn to the proximal end of a work element13. Therein, a body portion 428 of a work element 13 may be mechanicallycoupled to tendon actuating element 469 at the proximal end of a workelement. Note that a tendon actuating element 469, from the embodimentof FIGS. 2A and 2B, is already coupled to a body portion 428 throughtendons 468, 470, toward the distal end of a work element 13. That is,an entire work element 13 may be formed of a single homogeneousmaterial—such as from a single hollow tube that is (for example)laser-cut to form the structures shown in FIGS. 9A and 9B. Two beaks areshown. It is to be understood, however, that such need not be the case,as a work element 13 may comprise multiple beaks or a single beak thatacts against a non-moveable part, such as a fixed trough-shaped distalportion of a distal sheath or against a fixed, opposing beak that ispart of a work element 13 itself.

According to one embodiment, as shown in FIGS. 9A and 9B, the proximalend of a tendon actuating element 469 may be mechanically coupled to theproximal portion of a body portion 428. Such mechanical coupling may beconfigured to maintain a tendon actuating element centered on the cutoutin a body portion formed to accommodate a tendon actuating element 469and/or to provide additional biasing force in the distal direction, aswell as to aid in manufacturing. One embodiment comprises a resilientmember 427 having one end thereof coupled to a tendon actuating element469 and another end thereof coupled to a proximal portion of the workelement 13. Such a resilient member 427 may be configured to bias thebeak or beaks of a work element 13 in the open configuration, such thata sufficiently great proximally-directed force applied to a tendonactuating element 469 tends to close a beak or beaks. Conversely,release of such proximally-directed force causes a resilient member 427to release the energy stored during the extension thereof and return toits un-extended state, thereby exerting a distally-directed force on atendon actuating member 469, which causes a beak or beaks to return toits or their default open configuration.

Also shown in FIG. 9B, attachment holes 292A and 292B (similar infunction to 588 and 589 of FIG. 5 above) may be provided on a bodyportion 428 and on a tendon actuating element 469, respectively. Suchattachment holes 292 may, according to one embodiment, indicate thelocation of, for example, spot welds, as detailed below.

FIG. 10 shows a distal portion of a proximal sheath according to oneembodiment. A proximal sheath 300, as shown in FIG. 10 may comprise anumber of fenestrations or slots 304 that run through the wall of aproximal sheath 300, from an outer surface to an interior lumen thereof.The distal portion of a proximal sheath 300 may be configured to fitover and attach to the proximal end of a monolithic beak assembly 13 ofFIGS. 9A and 9B. During assembly of the present excisional device and asshown in FIG. 11, attachment holes 308A and 308B of a proximal sheath300 may be lined up with attachment holes 292A and 292B, respectively,of a monolithic beak assembly 13. A proximal sheath 300 may thus beattached to a monolithic beak assembly 13 at attachment points 292A,308A and 292B, 308B. According to one implementation, an attachmentpoint 308A of a proximal sheath 300 may be spot-welded to an attachmentpoint 292A of a tendon actuating member 469 of a monolithic beakassembly 13. Although not shown in these figures, correspondingattachment points may be provided on the hidden side of the device.Similarly, an attachment point 308B of a proximal sheath 300 may bespot-welded to an attachment point 292B of a body portion 428 of amonolithic beak assembly 13. As also shown in FIG. 10, the distalportion of a proximal sheath 300 may define a resilient or springportion, as shown at reference numeral 306.

FIG. 12 shows the distal portion of a distal sheath 320 (noted as 590 inprevious figures), according to one embodiment. A distal sheath 320 maybe configured to fit over a proximal sheath 300 and an attachment point326 of a distal sheath 320 attached to attachment point 310 on aproximal sheath 300, as shown in FIGS. 11 and 13. For example, anattachment point 326 of a distal sheath 320 may be spot-welded toattachment point 310 on a proximal sheath 300, as suggested in FIG. 13.A distal sheath 320 is transparently illustrated in FIG. 13, to showunderlying detail. It is to be understood that spot-welding is but onemethod of attaching constituent components of the present excisionaldevice to one another. Other attachment technologies may also be used,as appropriate. Once a distal sheath 320 is spot welded in place, itwill rotate in synchronicity with a beak assembly 13 and proximal sheath300, but will be able to move axially relative to proximal sheath 300.Such axial movement between distal and proximal sheaths will positivelyopen and/or close a beak or beaks of monolithic beak assembly 13, aspreviously discussed.

FIG. 14 shows one embodiment of the present excisional device, in astill further intermediate state of assembly. In FIG. 14, an outersheath 330 (also shown as 590 in previous figures, but now re-numberedto distinguish over a distal sheath 320) has been fitted over anassembly comprising a monolithic beak assembly 13, a proximal sheath 300and a distal sheath 320. For example, an outer sheath 330 may comprisepolyimide or may comprise or be formed of stainless steel among othersuitable materials. An outer sheath 330 may be configured to be manuallyrotating, non-rotating, or at least differentially-rotating with respectto an assembly comprising a monolithic beak assembly 13, a proximalsheath 300 and a distal sheath 320 and may further be configured to beremovable. That is, in this embodiment, while an assembly comprising amonolithic beak assembly 13, a proximal sheath 300 and a distal sheath320 may rotate at relatively high rates of speed (in the thousands ofrevolutions per minute, for example), an outer sheath 330 may be heldeither stationary or rotated as needed. This may be accomplishedmanually or otherwise actuated by any mechanical means. For example, theuser may rotate an outer sheath 330 a few tens of degrees at a time, asand when the procedure requires, and may remove or replace it before,during or after a procedure. An outer sheath 330 may extend distally tobeaks of a monolithic beak assembly 13 (similar to that shown in FIG.6), may expose a greater proportion of a monolithic beak assembly 13 ormay cover a significant portion of beaks, which may be controlled duringuse, according to embodiments.

According to one embodiment, an outer sheath 330 may be dimensioned soas to allow an annular space to exist between the inner wall of an outersheath 330 and the combined outer surfaces of a distal sheath 320 anddistal portion of a monolithic beak assembly 13. This annular space mayallow for flush to be introduced at selected stages in the procedure.The flush may provide lubrication for the rotation of an assemblycomprising an assembled monolithic beak assembly 13, a proximal sheath300 and a distal sheath 320, and may facilitate the rotation and thusthe transport of the cored and severed tissue specimen in the distaldirection. According to one embodiment, when the beak or beaks of amonolithic beak assembly is or are in the open configuration,fenestrations or slots 304 (FIG. 10) defined in a proximal sheath 300are not lined up with fenestrations or slots 324 (FIG. 12) defined in adistal sheath 320. However, according to one embodiment, when beak orbeaks are actuated, and beaks are closing, are closed or aresubstantially closed, then fenestrations or slots 324 defined in adistal sheath 320 become lined up (or substantially lined up) withcorresponding fenestrations or slots 304 defined in a proximal sheath300. In this state, if there is flush in an annular space between theouter surface of a distal sheath 320 and the inner wall of an outersheath 330, this flush will enter the interior lumen of the device(where the cored and severed tissue specimens are collected and aretransported). Moreover, as the flush may have been entrained intorotation in an aforementioned annular space as the assembly comprising amonolithic beak assembly 13, a proximal sheath 300 and a distal sheath320 rotates, the rotating flush may enter this interior lumen with someforce and may exert that force on any cored and severed tissue specimentherein. This flush may act as a lubricant as well to the specimencontained in the inner lumen of the device. According to one embodiment,a vacuum may be drawn within the interior lumen of the device. Accordingto one embodiment, the vacuum force imparted on the cored and severedtissue specimen, alone or together with force imparted on such specimenby flush entering this interior lumen, draws and transports the coredand severed tissue specimen in the proximal direction, for eventualtransport to a transfer magazine 27, for example.

Transport of cored tissue specimens may be aided by a shoulder shown at332 in FIG. 14. Indeed, such shoulder encompasses the location definedby the proximal end of a monolithic beak assembly 13 and the distal endof a proximal sheath 300 as well as the distal end of a distal sheath520. As the diameter of a proximal sheath 300 is somewhat greater thanthat of the proximal end of a monolithic beak assembly 13, the interiorlumen of a proximal sheath 300 is correspondingly larger than theinterior lumen of a monolithic beak assembly 13, and the interior lumenof a proximal sheath thus serves as an expansion chamber. As the coredand severed tissue specimen(s) enters the interior lumen of a monolithicbeak assembly 13, the tissue specimen(s) may be somewhat compressed.Such compression may be somewhat relieved as the tissue specimen(s)transitions from the lumen of a monolithic beak assembly 13 to thesomewhat greater diameter lumen of a proximal sheath 300, at shoulder332. This decompression of the tissue specimen(s) in the lumen of aproximal sheath 300 may, together with flush and/or vacuum, alsofacilitate tissue transport. A shoulder at 332 could expand an innerlumen diameter in the range of 0.001 inch to 0.100 inch additional overan original lumen diameter, or double a lumen diameter, whichever isgreater. As previously mentioned, shoulder features may be incorporatedinto a proximal sheath, distal sheath and outer sheath to augment suchtissue expansion/transport action. As previously mentioned may be thecase, such an embodiment may not incorporate a first helical element(transport helix) similar to that shown in FIG. 5 above, but may insteadbe constituted of co-axially disposed helices, in the form of a proximalsheath and a distal sheath, which, aided by flush and/or vacuum, mayefficiently transport tissue specimens axially to a transfer magazine atthe proximal end of the device 10.

According to one embodiment, flush may be incorporated in the annularspace between an outer sheath (which may actually take the form ofeither a distal sheath 590 or an outer sheath) and inner sheath(s), tofacilitate tissue transport. Vacuum may be drawn within the centrallumen of a whole tubular coring and transport assembly 11, to facilitatetissue transport as well as flush fluid transport. This enables anoperator to collect any fluids from the penetration and biopsy sitesduring the procedure in order to help with visualization under variousguidance modalities and to collect cells for cytological analysis.Moreover, according to one embodiment, such a flush pathway enables thedelivery of, for example, biologically active substances and/or markers.

Coupled with flush and vacuum, fenestrations defined in a proximalsheath and a distal sheath may enable a helical “pumping” feature andcreate a reservoir of fluids surrounding the tissue, which may enable aswirling wave action to interact with the cored and severed tissuesamples to gently push them in the proximal direction. Suchfenestrations may also lessen respective wall surface areas of thesestructures and thus decrease the surface friction experienced by thecored and severed tissue sample. Such structures also exhibit afavorable “sealing” effect surrounding the tissues, particularly whereirregular tissues might, based on their own surface architecture,engender vacuum leaks. Indeed, the gentle urging of such transportationof the cored and severed tissue samples preserves the underlying tissuearchitecture and delivers a clinically-useful sample (e.g., one whosetissue architecture has not been unacceptably damaged during itstransport) to, for example, a transfer magazine 27.

FIG. 15 is a side perspective view of a single split tube actuating androtating a work element 13, in yet another embodiment. In thisembodiment, proximal and distal sheaths previously discussed may bereplaced by a single tube, split along its long axis and incorporatingtravel limiting shapes (similar in functionality to element 467 of FIG.2B, although located differently) along the split length of the tube.These travel limiting shapes are shown in this figure as T-shapes, butother shapes may be selected or envisioned. As shown, the distal end ofone half, arbitrarily, the upper half 13C of the split tube may beattached to a tendon actuation member 469 while the distal end of theopposite (lower) half 13D, as shown by the cutout, may be attached to abody portion 428 of a monolithic beak assembly 13. In such aconfiguration, one half of the split tube acts on tendons of beaks whilethe opposing half acts on a body portion of a beak assembly or workassembly, thus allowing for axial movement between the upper and lowerhalves to constitute an actuation mechanism for opening and closingbeaks as well as rotation, since the upper and lower halves of such asplit tube necessarily rotate in synchronicity. An expansion chambersection proximal to a work assembly attachment point that was discussedabove would be present in such an embodiment. Furthermore, such axialmovement may be limited, in embodiments, by T-shaped or otherwise shapedtabs that may be formed as part of one or both tube halves slidingwithin travel limiting slots 467 in an opposing half of a split tube,according to one embodiment. Several of these tabs and slots may bearranged along the length of a split tube. Additionally, slot(s) 467 maybe filled with a flexible substance, such as silicone, that may also beprovided with a small hole that will open and close as a T-shaped tabmoves axially in the slot. According to embodiments, this may allowflush fluids drawn between an outer sheath 330 and a split tube innerelement to selectively pass into the central lumen of such a split tubeto aid in tissue specimen transport.

According to one embodiment, an entire assembly of split tube, beak,living hinge and tendons may be formed of a single tube that may be, forexample, laser cut (not shown, but easily envisioned wherein the lowerhalf, for example, continues to become the body portion of a beakassembly and the upper half of the split tube continues to become atendon actuating member, or vice versa). In the two embodimentsdiscussed under this figure, only two tubes (outer sheath and innersplit tube) are nominally present, and there may or may not be anyhelical elements at all associated with such embodiments.

Based upon the principles of distal work element (beaks) operations fromthe previous FIGS. 2 through 15, it may be seen that, according toembodiments, a rotating proximal sheath 584 or 300 (according tofigures) may serve to both rotate a single beak or multiple beaks, aswell as provide the mechanism for opening and closing such beak orbeaks, by being itself moved axially distally such that its distal endpushes up against a non- or differentially-rotating distal sheath 590 or320, or according to embodiments, such as of FIG. 13, by relative axialmovement between a proximal sheath and a distal sheath, allconfigurations and embodiments of which for this device 10 are referredto as a tubular coring and transport assembly 11 in FIG. 1. In the innerlumen of this coring and transport assembly 11, a first helical element582 may be provided to aid in tissue specimen transport proximally,which may be further aided or replaced by liquid flush introduced intothe central lumen at the distal end of an assembly 11 and/or vacuumintroduced at the proximal end of device 10. If provided, a firsthelical element 582 may rotate at a different speed than that of aproximal sheath and a beak element(s) 13. With these principles in mind,the following set of figures addresses the mechanical means of providingsuch actions to the distal end of device 10 of FIG. 1, according toembodiments. It may also be seen that the mechanical arrangementsdescribed herein are not the only arrangements that may accomplish allof these desired actions on a tubular coring and transport assembly 11,and other arrangements that may be envisioned by one skilled in the artare considered within the scope of this invention. It may also beenvisioned that elements such as a first helical element 582 may bedeleted, according to embodiments, but may still be illustrated in FIG.16 below to show how it or they may be integrated into a device 10, ifdesired.

FIG. 16 shows a top view of a mechanical arrangement for a tubularcoring and transport element 11 rotation and actuation, according to oneembodiment. From the left or distal side, a proximal end of a distalsheath 590 passes through a front seal 602, which in this view is at thedistal end of a housing or handle portion 12 of device 10 (an outersheath 330 is not shown in this view but may be present according toembodiments). A distal sheath 590 is free to move against an internalspring axially forward and back, the total distance of such movementbeing approximately equal to a maximum automatically orsemi-automatically obtained sample tissue length (not to scale). At itsproximal end, a distal sheath 590 is bedded into a tube socket/seal 603,which is itself attached to the forward wall of a distal sheath carrier606, which slides back and forth within a slide 605 to a maximumdistance defined by a carrier stop 604, both of which are formed in theouter housing of device 10 in this embodiment. Continuing to the rightof the illustration, a proximal sheath 584, contained within a distalsheath 590 and rotating independently of it, may be seen passing througha thrust bearing 609A in the forward wall of a proximal sheath carrier609, which itself slides axially inside a distal sheath carrier on aslide 608, and which is furnished with its own spring which effectivelyallows a return force to separate the two carriers if they are pushedtogether, which causes a proximal sheath to move backward or forward,respectively, in relation to a distal sheath. Recalling that it is thedifferential axial movement between a distal sheath and a proximalsheath that activates beak opening and closing, it may be seen that inthis embodiment, such axial movement may be accomplished by the actionof the two carriers in relation to one another. The total distancetraveled by proximal sheath carrier 609 therefore relates to the axialdistance traveled between a proximal sheath and a distal sheath to openor close a beak or beaks 13 at the distal end of device 10 according toembodiments.

A proximal sheath 584 is also free to move forward and backward,axially, under rotation as a result of a thrust bearing 609A describedabove. A proximal sheath 584 continues proximally in this illustrationthrough a vacuum seal 612 at the forward bulkhead of a vacuum chamber611, which serves to capture any stray fluids that are not aspiratedthrough the central lumen of a whole tubular coring and transportassembly 11 or through a transfer magazine 27. Rotational force for aproximal sheath 584 is provided by its gear 614, in this illustration,which is driven by a proximal sheath pinion gear 613. Also in thisillustration may be seen a first helical element 582, which may bedriven at a different rotational speed than that of a proximal sheath byits own gear 616 and pinion gear 615, which may also drive a vacuumsystem (not shown) of the present biopsy device. If such is provided, afirst helical element may terminate within a transfer magazine 27 inwhich tissue samples may be deposited as a result of device 10's action.

This illustration also shows that, according to one embodiment, thedistal and proximal sheath carriers may terminate proximally by verticalside walls of any shape, and upon which a rotating dual cam gear 620,with individual cams such as a distal sheath cam 618 and a proximalsheath cam 619 acting upon the vertical side walls of the two carriers.The inner side walls and cam 619 correspond to a proximal sheath carrier609 and the outer side walls and cam 618 correspond to a distal sheathcarrier 606. It may be envisioned that, depending on the side profile ofeach cam as well as the side profiles of the two vertical side walls,many different tunings may actuate the same or differential movement,acceleration and timing of differential movement of the two carriersrelative to each other, and thus to the combined and coordinated actionof a distal work element of device 10, according to embodiments. Forinstance, at the beginning of the rotation of twin gear cams 620 withtheir individual cam elements 618 and 619, the carriers may be actuatedequally, corresponding to forward movement of a distal sheath and aproximal sheath, thus coring tissue with beaks open and rotating. Uponreaching a certain axial distance, a cam 619 may continue forward,closing the beaks and keeping them closed while both distal and proximalsheaths retreat proximally carrying the tissue sample backwards anddelivering it to a transport mechanism for eventual delivery to, forexample, a transfer magazine 27. In such an embodiment, gentle tractionwould be applied to the tissue sample taken at the end of the part offstage of the biopsy device 10's action for that sample, further ensuringa positive part off from surrounding tissue. Many different cam/camfollower (vertical rear walls of the carriers) configurations or shapesmay be envisioned to provide forward and backward axial movementcombined with differential acceleration of individual sheaths to allowthe device 10 to accomplish its desired operations at different pre-,intra-, and post-operative stages of penetration, coring, part-off,retrieval and storage of sequential samples, as well as materialcollection from or delivery to the target site as described previously.For instance, a dimple in the center vertical section of an innercarrier vertical rear wall would result in a double closing of beaksafter a short time interval, which may result in further aiding positivepart off of the tissue sample. The vertical walls of each carrier may beasymmetrical to each other or in their upper or lower sections,depending on the mechanical effect desired. The cams themselves may beasymmetrical in their individual side shapes, which combined withspecial shapes imparted to the vertical rear walls of the carriers couldresult in extremely fine tuning of carrier axial movements at anydesired point in time, defined by the revolution speed and instantaneousradial angle during revolution of twin cam gears at any time. Twin camgears of this embodiment may be powered by a worm gear 621, which wouldallow for movement of the two carriers to be frozen in position at anydesired stage. A worm gear 621 is itself driven by a pinion gear 623operating through a simple clutch mechanism 622. It should also be notedthat at any time, carrier 609 and carrier 606 may be manually squeezedtogether through a simple mechanical linkage (not shown), which maycause beaks to close and part off or remain closed at an operator'schoice. It should also be noted that rotation and axial movement areindependent of one another with such an arrangement, and thus may becontrolled with different actuation mechanisms to allow the device 10 toaccomplish all of its intended functions. Again, this illustration isonly one of many different mechanical arrangements that may beenvisioned by one of skill in the art, all of which are considered to bewithin the scope of this disclosure, and that may be selected to enablethe device to accomplish any or all of the following actions consideredcharacteristic of device 10, according to embodiments:

-   -   Penetration to the target tissue site or withdrawal from the        site:        -   Beak(s) closed, no rotation        -   Beak(s) closed, with rotation        -   Beak(s) open, no rotation        -   Beak(s) open, with rotation;    -   Semi-automatic tissue sampling (gear cams stop after one        rotation);    -   Automatic tissue sampling (gear cams continue to rotate until        interrupted);    -   Short core sampling (using the manual part off function        described above); and    -   Continuous core sampling of any sample length, terminating in        manual part off.

FIG. 17 is an illustration of principles of a different arrangement of acam gear and cam follower arrangement, according to embodiments. Thisfigure specifically looks at the time based action of a geared cam 620but with two pins surrounded by bushings that act in a similar manner tocams 618 and 619 from FIG. 16, and are thus labeled as such in thisfigure. In this embodiment, a geared cam wheel 620 is assumed to rotatein a clockwise direction, with pin 618 (analogous in function to cam 618of FIG. 16) being a short pin that acts only on the inside of proximalsheath carrier's vertical rear wall, and pin 619 (analogous in functionto cam 619 of FIG. 16), which is a longer pin that is capable at timesof effectively acting on both a proximal sheath carrier 609 and a distalsheath carrier 606 vertical rear walls simultaneously. The arc distancebetween the two pins on the inner surface of a gear cam wheel shown bythe two angles “a”, using the analogy from FIG. 16, determines which ofthe two pins is acting on which carrier at any given point in time,either together or in a lead-lag relationship depending on therevolution position in time of the gear wheel as it rotates. Forpurposes of illustration, the larger arcs scribed in this figurecorrespond to the vertical rear wall surface of a distal sheath carrier606, and the smaller scribed arcs correspond to the vertical rear wallof a proximal sheath carrier 609. The pins 618 and 619 are shown withtheir bushings only at the start of the cycle, for purposes ofillustration, and are shown as dots at various other locations whichcorrespond to their movement at various time intervals with gear camwheel 620. A gear cam wheel 620 is shown to the right of the figure,with the arcs of the carriers extending to the left to correspond withthe independent carrier movement outlined in the previous FIG. 16. Itcan be seen that the longer pin 619 is a shorter radial distance fromthe center of a gear cam wheel 620 than the short pin 618, which pin 618acts only on a proximal sheath carrier 609. It is also lagging the longpin 619 in revolutionary time, which implies that it comes into playonly at a certain point in the clockwise movement of a gear cam wheel620. Recalling that if a proximal sheath carrier is pressed fartherdistally than a distal sheath carrier at any time (even manually by theoperator), the beak(s) will tend to close, following the principlesoutlined in previous figures, at a certain point in time (atapproximately the 8 o'clock position in this figure) the short pin willbegin to act independently on a proximal sheath carrier and extend itdifferentially farther distally than a distal sheath carrier, closingthe beak(s) and keeping them closed until that point in time (atapproximately the 2 o'clock position in this illustration) when thebeak(s) will again open in anticipation of another forward excursion ofboth proximal and distal sheaths for coring and sampling.

For purposes of illustration, it is assumed that the rest position ofthe two carriers is when a long pin 619 is in the 3 o'clock position. Inthis position, beak(s) are open (labeled as “A” or zero time in terms ofrotation time) and both distal and proximal sheath are at their closestproximal point to the housing of biopsy device 10. FIG. 17 includes asmall microswitch 632 with a pointer on a gear wheel, whose functioncould be to stop/restart gear wheel 620 revolution when a long pin 619is in its starting 3 o'clock position, which action may correspond tothe difference between semi-automatic (one revolution and microswitchstops revolution until disabled/re-enabled) and fully automatic(microswitch disabled altogether and thus rotation and samplingcontinues until operator interruption of the process) sampling action ofthe device 10, according to embodiments. The total excursion time of thedistal end of the device 10 (coring forward, part off, sample retrievaland transfer to the transport mechanism, return to starting position)occurs in a single revolution of a gear cam 620, and the individualactions of pins on individual sheath carriers 606 and 609 are asdescribed herein. Such total sample (excursion) time may vary from aslittle as 2 seconds to as long as 12 seconds, depending on embodiments,with a nominally designated time of 4 seconds, in one embodiment. If thetotal time for rotation is assumed to be 4 seconds, then rotationalposition “A” corresponds to zero, position “B” corresponds to one secondelapsed time, position “C” corresponds to that interval when the shortpin takes over and the beak(s) begin to close, position “D” correspondsto two seconds elapsed time (and wherein the beak(s) have closedcompletely as a short pin 618 reaches that position), position Ecorresponds to three seconds elapsed time, and the return to position Acorresponds to four seconds total rotation time, assuming constant speedof gear cam wheel 620, which may also be variable, according toembodiments. When a long pin is at the 3 o'clock position, it is actingon the vertical rear wall edges of both carriers simultaneously, whichcontinues to be the case until the long pin 619 has reachedapproximately the 9 o'clock position, at which time a short pin 618,lagging behind at a calculated arc distance “a” and further radiallythan the long pin, will start to engage only an inner proximal sheathcarrier vertical rear wall, continuing its forward traverse at themoment when a distal sheath carrier has ceased its maximum forward ordistal movement. The result is that the beak(s) will close, and remainclosed until the long pin reaches approximately the 1 o'clock position,thus withdrawing the sample under either continuing proximal sheathrotation or not, as desired (since rotation action of the proximalsheath, which rotates the beak(s) and forward/rearward excursion of thecarriers are independent of one another, as illustrated in FIG. 16). Asa long pin 619 reaches the 3 o'clock position, the beak(s) are fullyopen and ready for coring forward again and parting off and transferringanother sample to a transport mechanism and ultimately, for example, toa transfer magazine 27. Of note is that according to embodiments,sampling cycle time is a function of the time of one revolution of agear cam wheel 620, and that the timing for beak actuation is a simplefunction of the placement of short pin 618 in relation to long pin 619.The arched (in one embodiment) configuration of carrier vertical rearwalls is only one configuration, but different profile shapes of eachvertical rear wall will tend to accelerate or decelerate the actions ofthe pins on those surfaces, and many different vertical rear wallprofile shapes are possible, depending on embodiments. Additionally, theprofile shapes of vertical rear walls of carriers may differ from top tobottom to impose time based factors on the action (axial movement, withimplied beak actions associated with such excursions of the twocarriers, in relation to one another) of each individual carrier 606 or609, according to embodiments. Finally, in this illustrated embodiment,the axial distance horizontally between a short pin 618 and a long pin619 corresponds to the axial relative distance (and therefore time)necessary for travel of a proximal sheath carrier 609 compared to adistal sheath carrier 606 in order to accomplish beak(s) closure (shownas “b” in this figure as shown and discussed in FIGS. 5, 7 and 8 above.)Total excursion distance of the distal end of device 10 is shown as “c”in this figure, and is a function of the placement of pins 618 and 619and the diameter of a gear cam wheel 620, in one embodiment. Such totalexcursion distance may be of any length desired, according toembodiments, and for one embodiment, such distance is nominally 1 inchor 2.54 centimeters, corresponding to maximum automatic sample length.Again, it should be noted that samples of any length may be obtained bythe operator with device 10, as will be discussed further below.

FIG. 18 is a side view of a cutting element actuation mechanismconsisting of twin inner and outer sheath carriers, such as 606 and 609of FIG. 9, according to embodiments. From the preceding FIGS. 9 and 10,it may be seen that rotation of gear cam wheel 620 will slide bothcarriers axially distally and proximally, in differential movement toeach other as previously described. Also shown in this figure is adistal sheath 590 with its external return spring, a distal sheathsocket and flush connection 603, a proximal sheath 685, a proximalsheath thrust bearing 609A, a gear cam wheel 620 with its short bushedpin 618 and its long bushed pin 619, a gear cam wheel microswitch 632and a maximum forward travel proximal sheath carrier microswitch 633. Inthe embodiment shown in this figure, the vertical rear walls of eachcarrier 606 and 609 are profile shaped as hemi-circular in form and ofnearly the same size, although other embodiments may alter the shapes ofeither carrier rear vertical wall to be of any shape desired, which willaffect the action of the two carrier's axial movements, according toembodiments. The rear walls may have special features, such aselliptical shapes in their upper or lower halves, dimples, wavy shapesor any other shape desired, and one skilled in the art will recognizethat such profile features will act with the pins of a gear cam wheel toaccelerate or decelerate the individual axial movements of the twocarriers in relation to each other, all such designs and correspondingmovements of which are considered to be within the scope of thisinvention. Further, the profile shape of each of the two carriers maydiffer from each other, and the rear walls may be lowered in relation tothe long horizontal axis of each of the carriers, resulting in acantilevered action on the carriers as imparted by a gear cam wheel 620.This may be especially important for embodiments of device 10specifically designed for stereotactic table use, where keeping thecoring and transport assembly 11 of FIGS. 1 and 19 as near as possibleto the upper end of the device may be of benefit in allowing a “down thebarrel” view of the device in action, as well as for imaging mechanismswhere such a benefit has use in being placed as closely as possible tothe long axis of the working end (distal end) of the biopsy device,according to embodiments. According to other embodiments, the twocarriers and cam wheel may be replaced by thrust bearing carriers withpins that intersect the slots in a barrel cam, or that may be connectedto connecting rods and a crankshaft, for example, and any of these orother mechanical arrangements designed to allow rotation, relative axialmovement between a proximal and distal sheath, and forward excursion ofa tubular coring and transport assembly may be envisioned by one skilledin the art and are therefore considered to be within the scope of thisdisclosure.

FIG. 19 is a side view of internal and external features and elements ofa biopsy device 10, according to one embodiment. In this figure, themechanism of a distal sheath carrier 606 and proximal sheath carrier 609with their elements of FIGS. 16, 17 and 18 are shown in near scale size,according to embodiments. Other elements also shown in various previousfigures herein include a tubular coring and transport assembly 11, anon- or differentially-rotating distal sheath 590 (320), a work element13, a proximal sheath 584 (300), a distal sheath carrier 606, a proximalsheath carrier 609, a proximal sheath thrust bearing 609A, a distalsheath socket/flush port 603, a proximal sheath pulley 614 (analogous togear 614 of FIG. 16, as will also apply to other pulleys in this figure,which correspond to various gears of FIG. 16), a first helical elementpulley 616, a vacuum chamber 611, a first helical element or transporthelix 582 (which may be deleted, according to embodiments), a transfermagazine 27, a flush port 638 (which may be located at either end ofhandle portion 12), an aspiration/material delivery port 639 (not shownin this view but located at the proximal end of device 10 as indicatedherein), a rotation power switch/led indicator 635, a DC adapter port637, a DC motor 636, a transport helix pinion pulley 615, a proximalsheath pinion pulley 613, a worm gear clutch pinion pulley 623, a wormgear clutch 624, a worm gear clutch (gear cam wheel clutch) button 634,a worm gear pinion 621, a gear cam wheel 620, a drive mechanism carriercommon driveline 641, a manual part off button 633, batteries 652 in abattery carrier 653 and a battery carrier release lever 654. Also shownis that the top section of the device 10 may be detached along with thedistal end of the device and exchanged for a new entire top section,being secured by latch 651, according to embodiments. It should be notedthat, according to embodiments, many other substitutions for any or allof the elements noted herein that accomplish the same function orfunctions may be visualized by one skilled in the art, and all suchsubstitutions are considered within the scope of this invention. Itshould be noted that according to embodiments, rotation of a proximalsheath, first helical element, and distal sheath (if rotated) or outersheath (not shown) may be independent of the distal and proximal axialmovement of a tubular coring and transport assembly 11, and because ofthat feature, according to embodiments, the operator may select variousfunctions of the device 10 at any time, as described previously underFIG. 16 above.

Further aspects of the use of a transfer magazine 27 (also shown inFIG. 1) are now described, such that various clinical needs may befulfilled by permitting the operator of the present biopsy device toinspect the core samples more closely, and in some cases tactilely,without destroying the record keeping function of a transfer magazine27. Additional methods of ex-vivo imaging are also described, as are thesamples in the order in which they were collected and stored within astorage/record keeping transfer magazine 27, according to still furtherembodiments. Since a transfer magazine, according to embodiments, may beconfigured to be removable and/or replaceable at any time(s) during theprocedure, the present biopsy device enables a variety of proceduralmethods to ensue which would not be possible, or at least would beimpractical, without the structures disclosed herein. For example, usingthe present biopsy device, a clinician may segregate the contents of onetransfer magazine from the contents of another, additional transfermagazine. The operator of the present biopsy device may also have theability to interrupt coring/transport/storage with another function ofthe biopsy device, all the while, at operator's discretion, keeping thepresent biopsy device's shaft coring and transport assembly 11 in place,thus minimizing trauma associated with repeated removal from the bodyand insertion of these elements of the present biopsy device.

Indeed, according to one embodiment, a tissue biopsy method may compriseperforming coring/biopsy/transport cycles as described above.Thereafter, removing the transfer magazine and/or proceeding to markingand/or treatment phases may complete the procedure. The transfermagazine may then be removed and, if desired, placed under X-Ray,magnetic resonance imaging and/or ultrasound transducer orhigh-resolution digital camera if the transfer magazine is made of atransparent material. The core tissue specimens may then be imagedand/or recorded. The magazine may then be placed in a deliveryreceptacle, sealed and delivered to a lab for further analysis, makingnote of core lengths and correlating with imaging record(s) in-situ andex-vivo. Upon removal of transfer magazine from the present biopsydevice, the collected cores may then be visually inspected through thetransparent walls of the magazine. The magazine may then be split opento tactilely analyze the tissue specimens as desired. The magazine maythen be closed again, with the specimen therein. The magazine may thenbe deposited in a transport receptacle, sealed and delivered to a lab.

The transfer magazine may then be replaced with additional emptytransfer magazine(s) as needed to complete tissue collection during thebiopsy procedure. Alternatively, other cartridges/adapters or magazinesmay be fitted to the present biopsy device to deliver, for example,medications, markers and/or tracer elements, therapeutic agents, ortherapeutic and/or cosmetic implants to the biopsy site. The proceduremay then be terminated or continued, such as would be the case shouldthe practitioner desire to biopsy/core other nearby areas as deemedclinically useful.

As shown in this figure and previous figures, a device 10 with a smalldiameter distal end may be gently placed in proximity to or through alesion, or may be forward fired through the lesion using the internalmechanism of device 10, in embodiments. Clinically and procedurally, theability of a biopsy device to advance gently towards a target lesionprovides several advantages. Indeed, when a biopsy device does notadvance gently toward a target lesion or does not smoothly core throughdense target tissue, the operator may be led to exert excessive forceonto the biopsy device, thereby potentially forcing the biopsy deviceinto and even through adjacent structures. There have been instances ofbiopsy device components being broken off, requiring surgical removalthereof from the biopsy site when excessive force was needed in attemptsto obtain core samples from tissues such as dense breast tissue. Thepresent method of introducing a small diameter distal sheath, with thewithdrawn and closed beak(s) as a penetration mode in one embodimentherein and provided for with a specific cycle stage in the biopsy device10 of FIG. 1, enables an operator to gently and smoothly approach atarget lesion without requiring excessive manual axially-directed forceto be exerted on the present biopsy device by the operator or thestereotactic table itself, if used. It is to be noted that whenexcessive force must be exerted to advance conventional coring devicesthrough dense tissue, the resultant image provided by guidancemodalities may be significantly distorted by the force applied to theconventional coring device and transferred to the surrounding tissuewhich may cause the resultant image to be less distinct or blurred, andwhich, in turn, makes the biopsy procedure less accurate and much moredifficult technically. This force may also damage tissue, resulting inloss of tissue architecture and production of the aforementioned biopsyartifact. It is an important goal of all core biopsy procedures tofirmly establish that the core sample is taken from the highly specificimage area, notwithstanding the constraints imposed by the smalldimensions of the target tissue. Such small dimensions, therefore,require clear views of sharp margins to attain the kind of accuracyrequired during a biopsy procedure.

Flush mechanisms may be incorporated into the biopsy device 10,according to embodiments, to aid in tissue specimen transport to, forexample, a transfer magazine 27. Such mechanisms may consist of a distaltube socket/flush port 638 or 603, which may deliver flush fluids to thedistal end of the device between distal and proximal sheaths, forexample. Flush fluids and other materials may also be delivered to thetissue site through the central lumen of the device, with beak(s) closed(as described for liquids under FIG. 2A above through living hingeslots) or open, using an aspiration port 639, according to embodiments.Flush fluids may also be delivered to the distal tip through ports in acollar 593 of a distal sheath shown in FIG. 6 above. As previouslydescribed, fluids, solids and other materials may be delivered to thetissue site through the central lumen of the device, and various slotsand mechanisms such as the open beak(s) may be used in conjunction withflush fluids to gather and transport cells and liquids from the tissuesite for later cytological analysis.

Significantly, the coring and transport mechanisms and methods describedand shown herein are configured to apply traction while coring as beaksclose against each other and are then withdrawn to their restingposition, carrying the tissue specimen with them. That is, coring,cutting, parting-off, traction and transport may be, according to oneembodiment, carried out simultaneously. In so doing, as traction isapplied during a cutting event, the cutting event is not only renderedmore efficient, but may be the only way to successfully cut certaintissue types. This traction, according to one embodiment, may befacilitated by the continuous interaction of a helical element(s), atubular coring and transport assembly, and flush and vacuum, dependingon embodiments, which all or separately act together to provide gentlecontinuous traction beginning immediately upon the tissue entering thelumen of a tubular coring and transport assembly 11 of FIG. 1, andcontinuing during part-off of the tissue specimen. According to oneembodiment, the ratio between the twisting and pulling actions may becarefully controlled by, for example, control of rotation versus crankor cam speed, or other axial control mechanism. According to oneembodiment, when a beak assembly is open wider than the inner lumen of atubular coring and transport assembly, tissue may be drawn in by atleast surface treatment(s), channels, and helical elements, past a sharpbeak assembly and into the interior lumen of a tubular coring andtransport assembly. This may be, according to one embodiment, augmentedwith either flush or vacuum or both. However, it is to be noted that thetransport mechanisms and functionality described herein is moreeffective than vacuum alone, as vacuum predominantly acts locally at theproximal surface of a specimen. Indeed, transport mechanisms describedand shown herein (e.g., surface treatments, rifling, swirling fluidpumps, vacuum slots, helical element(s), and the selective rotation ofthese) may be configured to act along the entire length of the outersurface of the tissue specimen, which may be essential for certaintissue types. Vacuum, according to one embodiment, may well augment suchtraction and transport but need not be the primary modality be whichtissue specimen are drawn proximally or materials are pushed distally tothe target lesion site. According to one embodiment, vacuum may beprimarily used for extracting cells, body fluids and flush fluids, andto prevent the inadvertent injection of outside air, which can obscurean ultrasound image or transfer other unwanted elements into the body.

FIG. 20 represents a device 10 with simplified internal mechanism andcontrols, according to embodiments. Although this device 10 as shown inthis figure has few internal moving parts, it is still capable of all ofthe functions listed above under FIG. 16 above with the exception ofsemi-automatic and automatic sampling. Indeed, while much of the deviceas shown in the embodiment of this figure is designed for manualoperation (including a wind up motor 636 and simplified drive trainproviding rotational movement to a proximal sheath 584 and thus beaks 13and a first helical element 582), the configuration of distal endembodiments of the device 10, as shown in the previous figures, allowsfor forward and backward movement to be a function of operator action toposition the device as a whole, and for the device's function of singleinsertion/multiple samples to be realizable. The elements shown in thisfigure include the device 10, a tubular coring and transport assembly11, a work element 13, a flush port 638 which may be connected to asimple drip bag of saline solution as well as a (for example)drug/anesthetic delivery tube (not shown), a distal sheath socket 603, aproximal sheath carrier 609 with a thrust bearing 609A, a proximalsheath 584 and a first helical element 582, a transfer magazine 27, astart/stop rotational power switch 635 (note that its placement isdifferent for a simplified device 10 than that shown in FIG. 19, forexample) and a detachable upper unit of the device engaged at pivotpoint 656 and locked down by latch 651 to a handle portion 12, thusengaging the motor pinion gear to the driven gear powering a commondriveline 641. Also shown is a manual part off button 633, which allowsan operator to open or close beaks at any time, with or without rotationof the proximal sheath/first helical element (if the latter is used).Thus this simplified device may serve a useful purpose in developingcountries, for example. A transfer magazine 27 may serve as a port forvacuum (not shown), if used, or for delivery of materials to the tissuesite within the body down the central lumen of this simplified device,according to embodiments. If a first helical element is not used, alongwith any fluid flush or vacuum, the tissue sample may simply beaccumulated in a proximal sheath and eventually pushed back into atransfer magazine 27 by means of a rod 655 at the end of a procedure.Different embodiments of a simplified device may incorporate additionalinternal and external features of the device 10 of this invention,including for example a simple electric motor and rechargeablebatteries, some of which are shown in FIG. 19 above, and as describedherein.

The present biopsy device may be formed of or comprise one or morebiocompatible materials such as, for example, stainless steel or otherbiocompatible alloys, and may be made of, comprise or be coated withpolymers and/or biopolymer materials as needed to optimize function(s).For example, the cutting elements (such as the constituent elements of abeak assembly 13) may comprise or be made of hardened alloys or carbonfiber and may be additionally coated with a slippery material ormaterials to thereby optimize passage through living tissues of avariety of consistencies and frictions. Some of the components may bepurposely surface-treated differentially with respect to adjacentcomponents, as detailed herein in reference to a transporting tubularand storage component. The various gears or pulleys may be made of anysuitable, commercially available materials such as nylons, polymers suchas moldable plastics, and others. If used, the motor powering thevarious powered functions of the present biopsy device may be acommercially available electric DC motor. The handle portion of thepresent biopsy device may likewise be made of or comprise inexpensive,injection-molded plastic or other suitable rigid, easily hand heldstrong and light-weight material. The handle portion may be configuredin such a way as to make it easily adaptable to one of any number ofexisting guiding platforms, such as stereotactic table stages. Thematerials used in the present biopsy device may also be carefullyselected from a Ferro-magnetic standpoint, such that the present biopsydevice maintains compatibility with magnetic resonance imaging (MRI)equipment that is commonly used for biopsy procedures. Vacuum/deliveryassembly components may comprise commercially available vacuum pumps,syringes and tubing for connecting to the present biopsy device, alongwith readily available reed valves for switching between suction andemptying of materials such as fluids which may be suctioned by vacuumcomponents. The fluids collected by the embodiments of the presentbiopsy device in this manner may then be ejected into an additionalexternal, yet portable, liquid storage vessel connected to the tubing ofthe present biopsy device, for safe keeping for laboratory cellularanalysis.

The power source may comprise an external commercially available AC toDC transformer approved for medical device use and plugged into theprovided socket in the present biopsy device, or may comprise anenclosed battery of any suitable and commercially available powersource. The battery may be of the one-time use disposable (andoptionally recyclable) variety, or may be of the rechargeable variety.Additionally, other power sources, including mechanical motors orlinkages, compressed air or hydraulic motors may be used.

The cutting beak assembly of embodiments of the biopsy devices may beused, without alteration of their shape, attachment or any othermodification, to penetrate tissue on approach to a target lesion. Thecutting beak assembly may then be used to open and core the tissuespecimen, and to thereafter part-off the specimen at the end of thecoring stage. The beak assembly may also be used to help augmenttransport of the collected specimen. Having such multiple functionsintegrated in a single device saves valuable cross-sectional area, whichin turn creates a device that has a minimal outer diameter whileproviding the maximum diameter core sample. Maximizing the diameter ofthe core sample is believed to be significant from a clinicalstandpoint, since it has been demonstrated in multiple peer-reviewedjournals that larger diameter core specimens yield more accuratediagnoses. The clinical desire for large diameter core samples, however,must be balanced against the trauma associated with larger caliberdevices. Embodiments of the present biopsy device optimize the ratio sothat the clinician can have the best of both worlds. Advantageously,according to one embodiment, an internal helical transport system may beconfigured to augment the coring function of the forward cutting beaks.Helical transport coring elements may be configured to apply gentle,predictable traction on the cored specimen, during and after coring,which permits pairing the ideal speed of longitudinal excursion of thecoring elements of the present biopsy device with the ideal speed ofrotational movement of the same elements. In this manner, thearchitecture of the collected specimen is less likely to be disruptedduring transport. It has been shown in peer-reviewed scientific articlesthat preserving tissue architecture (i.e., preserving the architectureof the tissue as it was in vivo) to the greatest extent possiblefacilitates a more accurate diagnosis. A vacuum/delivery mechanism maybe configured to enable the force of vacuum to be exerted directly tothe coring transport components, such that coring and transport of thespecimen is handled as delicately, yet as surely, as possible andcomprises non-significantly dimension-increasing components such asprogressively sized fenestration features within tissue collectionareas. If the present biopsy device were to rely solely on vacuum fortissue transport, then vacuum artifact, which is a known and describedphenomenon associated with conventional biopsy devices, might be presentto a greater degree than is present (if at all) in embodiments describedherein. On the other hand, were embodiments of the present biopsy deviceto rely solely on a physical pushing or pulling mechanism to retrievecut specimen samples, crush artifact might be more prominent than isotherwise present when embodiments of the present biopsy device andmethods are used.

The internal surface treatments of an outer tube and a hollow, helicalinner component, when acting in concert; transport materials of avariety of phase states longitudinally without the need for complexcomponents that would otherwise contribute substantially to the outercaliber dimensions of the present biopsy device. Embodiments comprise ahollow helical transport mechanism that may be both strong and flexible,and which continues to function even when distorted by bending.Conventional biopsy devices typically cease to function properly ifdistorted even slightly. As such, the present biopsy device may beconfigured to define a curve along its longitudinal axis and in thiscase would still function properly, with minimal modifications.

Advantageously, a biopsy and coring device, according to embodiments,comprises features configured to perform medical core biopsy procedures,or shaping procedures (such as for vascular applications) or harvestingtissue for other uses. These features comprise structures configured forpenetration, coring, part-off, transport and storage of core specimensfor medical purposes such as diagnosis and treatment of a variety ofdiseases and abnormalities. Integral and detachable components may beprovided and configured to aspirate fluids for cellular analysis as wellas deliver materials at various selectable stages of the procedure. Thepresent biopsy device may be selectable for automatic and/orsemi-automatic function, may be used with or without image guidance, andmay be compatible with a variety of guidance imaging equipment such asultrasound, magnetic resonance imaging and X-ray imaging. The presentbiopsy device may be configured to be disposable and/or recyclable,highly portable, and delivered for use in sterile packaging, typical ofmedical devices having contact with internal body structures. Thepresent biopsy device may be configured to be minimally invasive. Asembodied herein, the present biopsy device comprises several featuresthat may be therapeutic in nature, to be utilized at various stagesalong the diagnosis/treatment pathway.

While certain embodiments of the disclosure have been described, theseembodiments have been presented by way of example only, and are notintended to limit the scope of the disclosure. Indeed, the novelmethods, devices and systems described herein may be embodied in avariety of other forms. Furthermore, various omissions, substitutionsand changes in the form of the methods and systems described herein maybe made without departing from the spirit of the disclosure. Theaccompanying claims and their equivalents are intended to cover suchforms or modifications as would fall within the scope and spirit of thedisclosure. For example, those skilled in the art will appreciate thatin various embodiments, the actual physical and logical structures maydiffer from those shown in the figures. Depending on the embodiment,certain steps described in the example above may be removed, and othersmay be added. Also, the features and attributes of the specificembodiments disclosed above may be combined in different ways to formadditional embodiments, all of which fall within the scope of thepresent disclosure. Although the present disclosure provides certainpreferred embodiments and applications, other embodiments that areapparent to those of ordinary skill in the art, including embodimentswhich do not provide all of the features and advantages set forthherein, are also within the scope of this disclosure. Accordingly, thescope of the present disclosure is intended to be defined only byreference to the appended claims.

The invention claimed is:
 1. An excisional device, comprising: a handleportion comprising a distal end and a proximal end; a work elementcoupled to the distal end of the handle portion and comprising a cuttingassembly that comprises only two articulable beaks including a firstarticulable beak and a second articulable beak that are configured toassume an open configuration, a closed configuration and to rotate, coreand part-off pieces of tissue, the work element being formed of a singletube of material that defines a radius of curvature and a longitudinalaxis and that comprises cuts and areas where the material is removednear a distal end of the work element to form at least the first andsecond articulable beaks such that a radius of curvature shared by thefirst articulable beak and the second articulable beak, when both are inthe open configuration, is the same as the radius of curvature of thesingle tube from which the work element is formed, the work elementbeing further configured to enable an axial movement, parallel to thelongitudinal axis, of a first portion of the work element relative to asecond portion thereof to cause the first and second articulable beaksto selectively open and close, wherein the cutting assembly isconfigured, during a single insertion thereof into a mass of tissue, torotate, core and part-off the pieces of tissue from the mass of tissue.2. The excisional device of claim 1, further comprising a gear cam inthe handle portion, the gear cam being configured to rotate untilinterrupted, in an automatic mode of operation of the excisional device,to cyclically core, part-off, transport and store the pieces of tissue,wherein, in the automatic mode of operation, the cyclically cored,parted-off and transported pieces of tissue have a same length.
 3. Theexcisional device of claim 1, further comprising a gear cam in thehandle portion, the gear cam being configured to rotate for onerotation, in a semi-automatic mode of operation of the excisionaldevice, to core, part-off, transport and store a single piece of tissueof the pieces of tissue each time an actuator on the handle portion isactuated.
 4. The excisional device of claim 1 configured, in a manualmode of operation, to core and part-off the pieces of tissue such thateach piece of tissue of the pieces of tissue is selectable in lengthupon actuation of a manual part-off mechanism on the handle portioncoupled to the work element.
 5. The excisional device of claim 1,configured to part-off the pieces of tissue at a selectable rate byselecting the axial movement of the first portion of the work elementrelative to the second portion thereof.
 6. The excisional device ofclaim 1, wherein the cutting assembly is configured to move, whilecoring, in a distal direction over a selectable excursion distance, topart-off the pieces of tissue to a selectable length.
 7. The excisionaldevice of claim 1, wherein at least one of the first articulable beakand the second articulable beak is articulable via a living hingeconfigured to selectively assume the open configuration suitable forcoring and the closed configuration, the closed configuration beingsuitable for parting-off tissue, tissue penetration and/or tissuedissection.
 8. The excisional device of claim 1, wherein the cuttingassembly is configured to move, while coring, in a distal direction overa selectable excursion distance.
 9. The excisional device of claim 1,wherein the single tube of material is a hypo tube.
 10. A method ofexcising tissue, comprising: providing an excisional device comprising ahandle portion, a work element coupled to one end of the handle portionand defining a longitudinal axis, the work element comprising a cuttingassembly that comprises only two articulable beaks including a firstarticulable beak and a second articulable beak that are configured toassume an open configuration, a closed configuration and to rotate,penetrate, core and part-off pieces of tissue, the work element formedof a single tube of material that defines a radius of curvature aboutthe longitudinal axis and comprising cuts and areas where the materialis removed near a distal end of the work element to form at least thefirst and second articulable beaks such that a radius of curvatureshared by the first articulable beak and the second articulable beak,when both are in the open configuration, is the same as the radius ofcurvature of the single tube from which the work element is formed, andcarrying out a single insertion of at least the cutting assembly into amass of tissue and, during the single insertion, rotating the cuttingassembly, penetrating the mass of tissue, axially moving one portion ofthe work element relative to another portion thereof in a directionparallel to the longitudinal axis to cause respective distal tips of thefirst and second articulable beaks to move perpendicularly to thelongitudinal axis to selectively open and close to enable coring throughthe mass of tissue and parting-off the pieces of tissue from the mass oftissue using the rotating cutting assembly.
 11. The method of excisingtissue of claim 10, further comprising operating the excisional devicein an automatic mode of operation, to repeatedly core, part-off,transport and store the pieces of tissue, wherein the repeatedly cored,parted-off, transported and stored pieces of tissue, in the automaticmode of operation, have a same length.
 12. The method of excising tissueof claim 10, further comprising operating the excisional device in asemi-automatic mode of operation, to core, part-off, transport and storea single piece of tissue of the pieces of tissue each time an actuatoron the handle portion is actuated.
 13. The method of excising tissue ofclaim 10, further comprising operating the excisional device in a manualmode of operation, to penetrate, core and part-off a selectable numberof the pieces of tissue of selectable length upon actuation of a manualpart-off mechanism on the handle portion coupled to the work element.14. The method of excising tissue of claim 10, further comprisingparting-off the pieces of tissue at a selectable rate.
 15. The method ofexcising tissue of claim 10, further comprising parting-off pieces ofthe pieces of tissue having an operator-selectable length.
 16. Themethod of excising tissue of claim 10, further comprising moving thecutting assembly over a selectable excursion distance during the singleinsertion.
 17. The method of excising tissue of claim 10, whereinproviding is carried out with the cutting assembly comprising a singlehypo tube.